DEVICE: Thinwall (05037881010823)

Device Identifier (DI) Information

Thinwall
920875T
In Commercial Distribution
920875T
VASCUTEK LTD
05037881010823
GS1

1
229053087 *Terms of Use
Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
CLOSE

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
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DXZ PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K963611 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a clean dry area
Handling Environment Temperature: between 0 and 35 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Dimension 8 x 75 mm
CLOSE

Device Record Status

bc2a963c-32af-4ece-b00a-50d614b8832b
July 06, 2018
3
October 22, 2015
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

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