Catalog Number

698343330

Brand Name

NA

Version/Model Number

698343330

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

GAC

Product Code Name

RASP, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

7c0ccd02-feb9-4e5c-a6ee-d7374149435a

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

June 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-