Duns Number:964053560
Device Description: Suture tape
Catalog Number
-
Brand Name
HS SutureTape
Version/Model Number
HS216
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
9fe889dd-1774-42c1-b8fc-6e5949178ddb
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
July 24, 2018
Package DI Number
10812444028642
Quantity per Package
6
Contains DI Package
00812444028645
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 1369 |
U | Unclassified | 8 |