Duns Number:249225954
Device Description: Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for overs Cut Length, White Braided, Polyethylene, Non-Absorbable Suture, Meets USP except for oversized diameter.
Catalog Number
-
Brand Name
AnchorKnot Suture
Version/Model Number
ASU-0-W-CL
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
K151009,K151009
Product Code
GAT
Product Code Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Public Device Record Key
82844c04-58ae-4041-b3e4-ff0b10c1cfb5
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
November 30, 2016
Package DI Number
10685447000416
Quantity per Package
10
Contains DI Package
00685447000419
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. | 1139 |