Hall 50 - Hall 50™ Oscillating Saw Battery Handpiece - Conmed Corporation

Duns Number:071595540

Device Description: Hall 50™ Oscillating Saw Battery Handpiece

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More Product Details

Catalog Number

PRO7300B

Brand Name

Hall 50

Version/Model Number

PRO7300B

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

HAB

Product Code Name

SAW, POWERED, AND ACCESSORIES

Device Record Status

Public Device Record Key

09a456bd-1ddb-4144-ada5-ad21546b041d

Public Version Date

October 22, 2021

Public Version Number

1

DI Record Publish Date

October 14, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CONMED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1412
2 A medical device with a moderate to high risk that requires special controls. 2261
3 A medical device with high risk that requires premarket approval 95