Duns Number:829465157
Device Description: Black Monofilament Nylon, Nonabsorbable Surgical Suture
Catalog Number
653H
Brand Name
ETHILON
Version/Model Number
653H
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
K946173,K946173
Product Code
GAR
Product Code Name
Suture, nonabsorbable, synthetic, polyamide
Public Device Record Key
316eb3e0-e147-43a3-82ef-39e5bcef8743
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
January 31, 2018
Package DI Number
30705031239559
Quantity per Package
36
Contains DI Package
10705031239555
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 |