Duns Number:528180159
Catalog Number
-
Brand Name
WEGO-PGCL Absorbable Surgical Suture With Needle
Version/Model Number
QB1262
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"
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
K142810,K142810
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
81d4c242-c075-4713-b2e3-192e6c7bf23d
Public Version Date
September 20, 2021
Public Version Number
4
DI Record Publish Date
April 18, 2016
Package DI Number
06941813635871
Quantity per Package
12
Contains DI Package
06941813630876
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 |