Catalog Number

3910-500-422

Brand Name

ICONIX

Version/Model Number

3910500422

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

K151201,K151201

Product Code

MBI

Product Code Name

Fastener, fixation, nondegradable, soft tissue

Public Device Record Key

8b0546af-2e82-4da5-a173-c735290269ee

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 22, 2016

Package DI Number

37613327283434

Quantity per Package

5

Contains DI Package

07613327283433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack