Catalog Number

3910-500-525

Brand Name

ICONIX

Version/Model Number

3910-500-525

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

4d2e3cbe-bcd1-4b1a-b59c-4a85878e6d78

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

August 26, 2015

Package DI Number

37613252450352

Quantity per Package

5

Contains DI Package

07613252450351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack