Catalog Number

-

Brand Name

Sklar

Version/Model Number

21-8092C

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

-

Product Code

HXK

Product Code Name

HOLDER, NEEDLE; ORTHOPEDIC

Public Device Record Key

41f5e51d-c1a3-405a-8ea0-d31ac2e540ae

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

August 14, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-