Duns Number:528180159
Catalog Number
-
Brand Name
WEGO-Nylon Non-absorbable Surgical Suture With Needle
Version/Model Number
NB4903
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2021
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
K080684,K080684
Product Code
GAR
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyamide
Public Device Record Key
74c0a19c-84ab-4f90-81c8-a78d97ea7947
Public Version Date
September 20, 2021
Public Version Number
6
DI Record Publish Date
November 06, 2015
Package DI Number
06941813647324
Quantity per Package
12
Contains DI Package
06941813642329
Package Discontinue Date
September 01, 2021
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2142 |