Duns Number:967358115
Device Description: CV-7 SUTURE 30" PT-09 DA 3 DZ
Catalog Number
7M04B
Brand Name
GORE-TEX Suture
Version/Model Number
7M04B
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"
-
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
P820083,P820083
Product Code
GAW
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Public Device Record Key
78b48268-f7aa-4410-a176-40e06ff63496
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
February 13, 2017
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. | 561 |
3 | A medical device with high risk that requires premarket approval | 623 |