Duns Number:058614483
Device Description: Absorbable Suture
Catalog Number
-
Brand Name
Chromic Gut
Version/Model Number
3-CG-813
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 26, 2021
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
25b740fd-352a-4708-82c8-e497b06b277d
Public Version Date
October 10, 2022
Public Version Number
8
DI Record Publish Date
August 28, 2015
Package DI Number
20884521120195
Quantity per Package
24
Contains DI Package
10884521120198
Package Discontinue Date
April 26, 2021
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 |