Catalog Number

3910-200-036

Brand Name

PEEK Zip

Version/Model Number

3910-200-036

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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

K070758,K070758

Product Code

MBI

Product Code Name

FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Public Device Record Key

bb08cd88-c558-471d-8d90-b7d76d392b53

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

September 04, 2015

Package DI Number

37613252232491

Quantity per Package

5

Contains DI Package

07613252232490

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack