Duns Number:017524666
Device Description: Knotless Barbed PDO Sutures with Stopper. 2/0, 18" 36mm Taper Pt 1/2 Cir, Pc.
Catalog Number
B-D218T36
Brand Name
UNIFY
Version/Model Number
B-D218T36
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
K193209,K193209,K193209
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
3257deae-e9d1-4c63-8d4f-f744aef8099e
Public Version Date
February 28, 2022
Public Version Number
1
DI Record Publish Date
February 18, 2022
Package DI Number
10814639025740
Quantity per Package
6
Contains DI Package
00814639025743
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |