Gauthier Biomedical - Multi-Color Ratcheting T-Handle - GAUTHIER BIOMEDICAL, INC.

Duns Number:015227072

Device Description: Multi-Color Ratcheting T-Handle

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More Product Details

Catalog Number

G900100

Brand Name

Gauthier Biomedical

Version/Model Number

G900100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

5b89b17a-2910-492e-b5c9-b5229c27109f

Public Version Date

May 11, 2022

Public Version Number

2

DI Record Publish Date

August 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GAUTHIER BIOMEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 39