Duns Number:058614483
Device Description: Absorbable Suture
Catalog Number
-
Brand Name
Plain Gut
Version/Model Number
SG-1632G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 08, 2015
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
K885018,K885018
Product Code
GAL
Product Code Name
SUTURE, ABSORBABLE, NATURAL
Public Device Record Key
de21fd48-4c0e-4372-bd7a-b0be3c1bc980
Public Version Date
January 28, 2022
Public Version Number
5
DI Record Publish Date
September 02, 2015
Package DI Number
20884521134628
Quantity per Package
12
Contains DI Package
10884521134621
Package Discontinue Date
October 08, 2015
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 |