Catalog Number

14-1078

Brand Name

Batrik Pin-Kaps

Version/Model Number

14-1078

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

Yes

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

22145f7f-15c7-41f8-a231-67cd416e0dea

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 25, 2020

Package DI Number

00690521004627

Quantity per Package

40

Contains DI Package

00690521014169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box