Catalog Number

V397-M

Brand Name

RELI®

Version/Model Number

V397-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

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

9c057709-5c80-40f9-9c33-cf87a2b6bcc7

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

May 13, 2019

Package DI Number

20386120010308

Quantity per Package

30

Contains DI Package

10386120010301

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case