Duns Number:229053087
Device Description: Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLA Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LINE
Catalog Number
920675TS
Brand Name
Thinwall
Version/Model Number
920675TS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963611
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
e9f60e74-cd0c-4660-80c2-8d5ca9422b41
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
October 22, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1682 |
| 3 | A medical device with high risk that requires premarket approval | 40 |