DEVICE: Hemagard Carotid Patch (00384401015161)

Device Identifier (DI) Information

Hemagard Carotid Patch
HGKTP08/150CPUT(1)
In Commercial Distribution
HGKTP08/150CPUT(1)
INTERVASCULAR SAS
00384401015161
GS1

1
382174019 *Terms of Use
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
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Device Characteristics

Labeling does not contain MRI Safety Information
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 A sterile 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
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K983819 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Room Temperature
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Clinically Relevant Size

[?]
Size Type Text
Width: 8 Millimeter
Length: 150 Millimeter
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Device Record Status

5f1c8002-da73-4ca1-ac0d-9e26c2aea61d
July 06, 2018
3
September 25, 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
Yes
No CLOSE

Customer Contact

[?]
+33442084646
cardiovascular.vics@getinge.com
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