Duns Number:528180159
Catalog Number
-
Brand Name
WEGO-Polyester Nonabsorbable Surgical Suture With Needle
Version/Model Number
EB1482
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
K080684,K080684
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
f3f4ebe4-deac-4777-bd98-1fedba9cea0a
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
April 19, 2016
Package DI Number
06941813666462
Quantity per Package
12
Contains DI Package
06941813661467
Package Discontinue Date
-
Package Status
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 |