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| Devon
Innovations
soon to become the first and only Indian manufacturer of Double 'J' Stents
to have an ISO 9001 : 2000 Certification. |
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Quite simply, it's quality by design. Whether it's the raw material,
the manufacturing process or the packaging we provide, we take great
care to ensure that the product you get is world-class.
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Raw Material
Our Double 'J' Stents are made out of Tecoflex - one of the most
advanced aliphatic polyurethane materials used in medical applications
requiring high levels of biocompatibility, biostability and processability.
IUI Catheters are made of Non-Toxic Medical Grade Polypropylene and
are now also available in PTFE (Teflon, in both straight and curved
options).
Tecoflex Polyurethane
Tecoflex Aliphatic Polyurethane comes from a very versatile family of
elastomerics. Body tissue and blood present difficult environments for
elastomeric components of indwelling medical products. Tecoflex is an
excellent material for implantation into the body, producing minimal
tissue reaction or blood clotting.
These components must be able to withstand extended exposure to aqueous
environments, body temperature, and the corrosive biochemical
composition of blood and body fluids which can degrade many materials.
The device must cause as few complications to the patient as possible.
Blood clotting, rejection responses, tissue inflammation and leaching of
toxic chemicals into the body must all be minimised for a material to
meet the safety requirements for implanted devices. |
Tecoflex which is used to manufacture Devon Double 'J' Stents meets
all the above requirements.
Characteristics of Tecoflex Polyurethane:
- High Radiopacity
- Hydrolytically stable
- Least Thrombogenic
- Very Low Encrustation
- Consistent Dimensional Stability
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Tecoflex has successfully passed critical biocompatibility and
biostability tests using standard biological toxicity and long term
implants, as given below. All the tests were performed by Toxicon Inc.,
Massachusetts, USA, in accordance with the International Standards
Organisation's Biological Evaluation of Medical Devices*.
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Biocompatibility Testing
Minimum Essential Medium
(MEM) testing for biological reactivity ISO
1993-5Hemolysis
Testing ISO 10993-4: |
- Acute Systematic Test ISO 10993-11
- Acute Intracutaneous Test ISO 10993-10
- Implant Test ISO 0993-6
>
Histopathology Tests: Subcutaneous implant into rabbits for 90 days
> Mutagenicity Testing
> Pyrogen Tests
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Biostability Testing
30 days and 90 days subcutaneous testing in rabbits.
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Quality Assurance
Each batch of imported raw material comes with Quality Assurance
Certification from the manufacturer. We have a
legitimate manufacturing license for Life saving devices.
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Packaging
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| Our safeguard against duplication.
Devon Double 'J' Stents come in a tamper-proof imported packaging
manufactured by Wipak Medical of Finland. These peel-open pouches are
constructed from transparent multi-layer plastic film and 70 gram
medical grade paper in accordance with ISO 9001 standards, which ensures
excellent retention of sterility.
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Manufacturing Process |
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Stringent
standards to ensure the finest quality
A decade
ago, before Devon came into the market, the only options doctors had
were exorbitantly priced imported Double 'J' Stents. Devon has
successfully introduced the finest quality stents manufactured using
imported custom made Aliphatic Radiopaque Polyurethane in India. We were
the pioneers in indigenous manufacture of catheters and we strictly
adhere to proven Good Manufacturing Process (GMP) guidelines. We have a
legitimate manufacturing license for Life Saving Devices and we will
soon become the first and only Indian manufacturer of Double 'J' Stents
to have an ISO 9001 : 2000 Certification.
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Injection Moulding- Cap Luers of various dimensions manufactured
in-house, ensuring strict quality control.
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Extrusion of Catheter Tubing - 3F to 24F from a variety of raw material including Polyurethane, Polyethylene, Ethyl Vinyl Acetate, Polyvinyl Chloride and Polypropylene conforming to International Medical Grade Specifications.
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| Products meticulously crafted in sterile environment, under strict
quality control, ETO sterilised and packed. |
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