Catalog Number

909848

Brand Name

ToggleLoc™ With Ziploop™

Version/Model Number

909848

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

K083070,K130033,K973775

Product Code

JDR

Product Code Name

Staple, fixation, bone

Public Device Record Key

45331574-532c-4cf4-a06b-c623bb19f2d4

Public Version Date

May 11, 2020

Public Version Number

6

DI Record Publish Date

May 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-