Duns Number:079402290
Device Description: Violet Monofilament (Polydioxanone), Synthetic Absorbable Surgical Suture
Catalog Number
PDP464H
Brand Name
PDS
Version/Model Number
PDP464H
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061037,K061037
Product Code
NEW
Product Code Name
Suture, surgical, absorbable, polydioxanone
Public Device Record Key
fda4be08-038c-4adc-8039-8b0196bf68f2
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
November 11, 2020
Package DI Number
30705031462490
Quantity per Package
36
Contains DI Package
10705031462496
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1028 |
| 3 | A medical device with high risk that requires premarket approval | 15 |
| U | Unclassified | 1 |