Catalog Number

12-0010

Brand Name

N/A

Version/Model Number

12-0010

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GDG

Product Code Name

HOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

006aafe1-bbc2-429b-9285-2634cb58ae66

Public Version Date

September 22, 2020

Public Version Number

3

DI Record Publish Date

August 23, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-