Duns Number:079402290
Device Description: Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
Catalog Number
D10030
Brand Name
PROLENE
Version/Model Number
D10030
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
K133356,K811872,K133356,K811872
Product Code
DXZ
Product Code Name
PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
Public Device Record Key
4c39cf91-c003-4e2f-8683-512ed59a0ec3
Public Version Date
May 10, 2022
Public Version Number
7
DI Record Publish Date
September 01, 2015
Package DI Number
20705031134215
Quantity per Package
6
Contains DI Package
10705031134218
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 |