Catalog Number

738B

Brand Name

MONOMID

Version/Model Number

738B

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

430183d1-4847-4be8-bd55-b8253dd838ce

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

December 21, 2015

Package DI Number

20790986002627

Quantity per Package

12

Contains DI Package

10790986002620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-