Catalog Number

909874

Brand Name

TOGGLELOC™ WITH ZIPLOOP™

Version/Model Number

909874

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K130033

Product Code

JDR

Product Code Name

Staple, fixation, bone

Public Device Record Key

368ad236-b3f6-45b7-9dc5-c475c2760fd6

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

May 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-