Catalog Number

110017308

Brand Name

TOGGLELOC WITH ZIPLOOP

Version/Model Number

110017308

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

K141263

Product Code

JDR

Product Code Name

STAPLE, FIXATION, BONE

Public Device Record Key

939a6117-9a1e-4131-b2bd-7c26f1cf1bbb

Public Version Date

March 21, 2019

Public Version Number

5

DI Record Publish Date

November 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-