Duns Number:079402290
Device Description: Violet Monofilament (Polydioxanone), Absorbable Surgical Suture
Catalog Number
Z9237T
Brand Name
PDS
Version/Model Number
Z9237T
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
NEW
Product Code Name
Suture, surgical, absorbable, polydioxanone
Public Device Record Key
1eb90b09-f8f3-426f-afe5-fc2faac30d56
Public Version Date
March 21, 2022
Public Version Number
2
DI Record Publish Date
August 09, 2021
Package DI Number
30705031467297
Quantity per Package
24
Contains DI Package
10705031467293
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 |