Catalog Number

32-467608

Brand Name

AGC ANATOMIC

Version/Model Number

32-467608

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

HTJ

Product Code Name

GAUGE, DEPTH

Public Device Record Key

6224f878-b26c-49de-ba0d-d4de16f558f6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-