Catalog Number

GB414R

Brand Name

AESCULAP

Version/Model Number

GB414R

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

HXY

Product Code Name

BRACE, DRILL

Public Device Record Key

cfe2a9b0-e1b4-4c64-ac2b-f95a0c82565c

Public Version Date

June 16, 2022

Public Version Number

2

DI Record Publish Date

August 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-