Duns Number:807404611
Device Description: Individual package contains six, 30 inch USP size 1 silk sutures. There are 12 individua Individual package contains six, 30 inch USP size 1 silk sutures. There are 12 individual packages per box.
Catalog Number
307S
Brand Name
N/A
Version/Model Number
307S
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
GAP
Product Code Name
Suture, Nonabsorbable, Silk
Public Device Record Key
bc855e59-e0cd-4b11-89f5-2890022065f4
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
December 21, 2015
Package DI Number
20790986002764
Quantity per Package
12
Contains DI Package
10790986002767
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Individual
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 461 |