DEVICE: Gelseal™ (05037881100661)

Device Identifier (DI) Information

Gelseal™
434026/10
In Commercial Distribution
434026/10
VASCUTEK LTD
05037881100661
GS1

1
229053087 *Terms of Use
Gelseal Gelatin Impregnated Knitted Vascular Prosthesis ANTE-FLO
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Synthetic vascular graft A sterile 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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FDA Product Code

[?]
Product Code Product Code Name
MAL GRAFT, VASCULAR, SYNTHETIC/BIOLOGIC COMPOSITE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P890045 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store in a clean dry area. Prosthesis must be implanted within one month after removal from the foil pouch.
Handling Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Branch length 15 cm
Device Size Text, specify: Branch diameter 10 mm
Length: 40 Centimeter
Lumen/Inner Diameter: 26 Millimeter
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Device Record Status

47e29ff0-ab10-4ab2-b6dc-082d70cfb4d9
July 06, 2018
3
October 24, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)262-3304
xx@xx.xx
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