Catalog Number

-

Brand Name

CoLS universal guide handle V5

Version/Model Number

264930

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113591,K120740

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

baed2568-e6c9-4c5e-8110-1137c537f864

Public Version Date

March 21, 2019

Public Version Number

1

DI Record Publish Date

March 13, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-