DEVICE: SealPTFE™ (05037881003467)
Device Identifier (DI) Information
SealPTFE™
T7005ES
Not in Commercial Distribution
T7005ES
VASCUTEK LTD
T7005ES
Not in Commercial Distribution
T7005ES
VASCUTEK LTD
SEALPTFE ion Gelatin Sealed ePTFE Vascular Prosthesis Ultrathin
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35281 | Synthetic vascular graft |
An implantable artificial substitute for a blood vessel intended to replace or bypass the diseased or injured vessel. It is typically made of woven or knitted polyethylene terephthalate (Dacron) or polytetrafluoroethylene (PTFE) fabrics and is best suited for large (more than 10 mm) diameter, high-flow vessel replacement (e.g., aortic or aorto-iliac artery reconstruction) and also for haemodialysis access and extra-anatomic bypass grafting. The device is used in many vascular bypass procedures (e.g., aorto-iliac, femoral-popliteal, axillo-axillary artery) except those involving the coronary arteries.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAL | GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in a clean dry area. Do not expose ePTFE products to temperature greater than 500°F (260 °C). |
Handling Environment Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Length: 70 Centimeter |
Lumen/Inner Diameter: 5 Millimeter |
Device Record Status
835b9915-76d5-4a20-9015-0e0f13a46c93
February 05, 2021
5
October 19, 2015
February 05, 2021
5
October 19, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)262-3304
xx@xx.xx
xx@xx.xx