Duns Number:023904428
Device Description: SUTURE, GUT CHR 5-0 18" P-3 (12/BX)
Catalog Number
-
Brand Name
McKesson
Version/Model Number
S687G
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
K142656,K142656
Product Code
GAL
Product Code Name
Suture, Absorbable, Natural
Public Device Record Key
17d42989-876b-4ac5-93a7-0f169095ae9e
Public Version Date
February 05, 2021
Public Version Number
4
DI Record Publish Date
December 09, 2016
Package DI Number
20612479213122
Quantity per Package
12
Contains DI Package
10612479213118
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |