Duns Number:023904428
Device Description: SUTURE 3-0, PGA-PCL, Undyed Monofilament, U.S.P. except for diameter 3-0 (2.0 Metric) 18"/ SUTURE 3-0, PGA-PCL, Undyed Monofilament, U.S.P. except for diameter 3-0 (2.0 Metric) 18"/46cm Synthetic Absorbable Surgical Suture, DSM19 Precision Reverse Cutting 3/8 Circle 19 mm
Catalog Number
-
Brand Name
McKesson
Version/Model Number
SY497G
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"
Yes
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
-
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
fa18db81-b41a-4f6c-b25e-1bfd5acbeedf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 09, 2016
Package DI Number
20612479189939
Quantity per Package
12
Contains DI Package
10612479189925
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 |