Catalog Number

-

Brand Name

Riverlon

Version/Model Number

192BKC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

68aaab5f-61b2-4e6d-9a6d-797fc6a967f8

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

January 08, 2021

Package DI Number

10810020082422

Quantity per Package

12

Contains DI Package

00810020082425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-