Duns Number:079402290
Device Description: Absorbable Surgical Suture
Catalog Number
853H
Brand Name
ETHICON
Version/Model Number
853H
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K946173,K946173
Product Code
GAL
Product Code Name
SUTURE, ABSORBABLE, NATURAL
Public Device Record Key
b46e5566-c59a-4dd3-816e-b2198511c7ad
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2015
Package DI Number
30705031016839
Quantity per Package
36
Contains DI Package
10705031016835
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |