Duns Number:879187821
Device Description: REDIDIOX PRO VIO MF 4-0 YFS-2 30"
Catalog Number
ML397-M
Brand Name
RELI®
Version/Model Number
ML397-M
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"
Yes
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
K172659,K172659,K172659
Product Code
NEW
Product Code Name
Suture, Surgical, Absorbable, Polydioxanone
Public Device Record Key
15d0726b-3de8-4c99-b7b8-e50a51c66672
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
May 13, 2019
Package DI Number
20386120010537
Quantity per Package
30
Contains DI Package
10386120010530
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 |