DEVICE: VasCure for Carotid Repair (00859389005096)

Device Identifier (DI) Information

VasCure for Carotid Repair
CMCV-073-609
In Commercial Distribution

AZIYO BIOLOGICS, INC.
00859389005096
GS1

1
080251450 *Terms of Use
VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
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Device Characteristics

MR Safe
No
No
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
Cardiovascular patch, animal-derived An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
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FDA Product Code

[?]
Product Code Product Code Name
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K111187 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Height: 1 Centimeter
Width: 10 Centimeter
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Device Record Status

b973391b-ac9b-492c-ae7d-5dbe7ea8f6c0
February 05, 2021
6
July 01, 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
10859389005093 5 00859389005096 2018-12-31 Not in Commercial Distribution Box
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Secondary DI

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

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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
No
Yes
No
No CLOSE

Customer Contact

[?]
470-514-4080
xxx@xx.xx
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