Duns Number:879187821
Device Description: REDIDIOX Monofilament Polydioxanone, Violet, 4-0, MFS-2
Catalog Number
-
Brand Name
Reli
Version/Model Number
ML397-SI
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
-
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
7b43e934-8168-4761-a8ec-067d0f8966d9
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
August 20, 2016
Package DI Number
20386120007223
Quantity per Package
30
Contains DI Package
10386120007226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 471 |