Duns Number:079402290
Device Description: Undyed Monofilament (Polydioxanone), Absorbable Surgical Suture
Catalog Number
Z495ZG
Brand Name
PDS
Version/Model Number
Z495ZG
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
8be204ad-6a4d-4086-a8e6-73c18bf6a19d
Public Version Date
July 04, 2022
Public Version Number
1
DI Record Publish Date
June 24, 2022
Package DI Number
30705031461721
Quantity per Package
12
Contains DI Package
10705031461727
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 |