Equinoxe - RETRACTOR, CHANDLER - Exactech, Inc.

Duns Number:157565946

Device Description: RETRACTOR, CHANDLER

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

317-20-07

Brand Name

Equinoxe

Version/Model Number

317-20-07

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

036abb82-78f0-4a55-8b92-7cbd917169d3

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EXACTECH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3717
2 A medical device with a moderate to high risk that requires special controls. 7206
3 A medical device with high risk that requires premarket approval 28