Catalog Number

3910-500-312

Brand Name

ICONIX

Version/Model Number

3910500312

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

K133671,K133671

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Public Device Record Key

50b5242c-2f2f-4ac9-8f36-c7c9d4a97b6e

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 14, 2015

Package DI Number

37613327176927

Quantity per Package

5

Contains DI Package

07613327176926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack