ORTHOMED - BRUNS CURETTE 6 1/4"HOLL.ROUND #000 - ORTHO-MED, INC.

Duns Number:086618626

Device Description: BRUNS CURETTE 6 1/4"HOLL.ROUND #000

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


More Product Details

Catalog Number

OM 49-0120

Brand Name

ORTHOMED

Version/Model Number

OM 49-0120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

HTF

Product Code Name

Curette

Device Record Status

Public Device Record Key

72f7389c-ee63-4cfc-857c-817713083d89

Public Version Date

June 10, 2021

Public Version Number

1

DI Record Publish Date

June 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO-MED, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 938
2 A medical device with a moderate to high risk that requires special controls. 155