Catalog Number

3910-500-391

Brand Name

OMEGA

Version/Model Number

3910500391

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"

-

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

K181083,K181083

Product Code

MBI

Product Code Name

Fastener, fixation, nondegradable, soft tissue

Public Device Record Key

8e0c9e7f-7c8a-47c8-9813-fd49e3992197

Public Version Date

November 02, 2020

Public Version Number

3

DI Record Publish Date

January 02, 2019

Package DI Number

37613327464796

Quantity per Package

5

Contains DI Package

07613327464795

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack