Catalog Number

-

Brand Name

Sklar®

Version/Model Number

65-7523

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"

Yes

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

K945541

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

60f7ebf1-117f-41ec-8a12-16a7b659c30b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-