Catalog Number

3910-500-653

Brand Name

OMEGA

Version/Model Number

3910500653

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

d8eea214-9403-4a5c-b1b8-2b8c70217f8e

Public Version Date

October 08, 2020

Public Version Number

1

DI Record Publish Date

September 30, 2020

Package DI Number

37613327514149

Quantity per Package

5

Contains DI Package

07613327514148

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack