Duns Number:058614483
Device Description: Monofilament Stainless Steel
Catalog Number
-
Brand Name
Steel
Version/Model Number
88862420-83
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
K955723,K955723
Product Code
GAQ
Product Code Name
SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE
Public Device Record Key
8c9fe23d-031a-4b50-b37f-32a27c7d4db9
Public Version Date
July 22, 2022
Public Version Number
7
DI Record Publish Date
August 31, 2015
Package DI Number
20884521102689
Quantity per Package
12
Contains DI Package
10884521102682
Package Discontinue Date
-
Package Status
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 |