DEVICE: Gelweave™ (05037881004778)
Device Identifier (DI) Information
Gelweave™
730034ADPSL
In Commercial Distribution
730034ADPSL
VASCUTEK LTD
730034ADPSL
In Commercial Distribution
730034ADPSL
VASCUTEK LTD
Gelweave Gelatin Impregnated Woven Vascular Prosthesis FLORIDA SLEEVE
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 |
---|---|
DSY | PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K013022 | 000 |
K162794 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store in clean, dry area at room temperature. The prosthesis must be implanted within one month after removal from the foil pouch. |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 34 Millimeter |
Length: 15 Centimeter |
Device Record Status
ea1097af-7de8-422b-ac4f-f982b144f78d
February 05, 2021
6
October 19, 2015
February 05, 2021
6
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)888-3786
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com