Duns Number:058614483
Device Description: Braided Absorbable Suture, P-13, 1x Undyed Strand
Catalog Number
-
Brand Name
Polysorb
Version/Model Number
GLS323GMDL
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 2022
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
K963253,K963253
Product Code
GAM
Product Code Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Public Device Record Key
2ff3cc71-fe40-4a18-936f-60063795b89d
Public Version Date
January 28, 2022
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
20884521212463
Quantity per Package
12
Contains DI Package
10884521212466
Package Discontinue Date
January 25, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |