Duns Number:879187821
Device Description: REDICAPRONE-25 Monofilament Poliglecaprone 25, Violet, 0, MFSL, 36”
Catalog Number
MS987-SI
Brand Name
RELI®
Version/Model Number
MS987-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
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
f527d8ce-8540-4e34-acb0-7edd30ce0a25
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
August 09, 2019
Package DI Number
20386120010780
Quantity per Package
30
Contains DI Package
10386120010783
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 |