NA - Oscillator Blade, Coated, 19.5/14 x 90 x 1.19mm - Conmed Corporation

Duns Number:071595540

Device Description: Oscillator Blade, Coated, 19.5/14 x 90 x 1.19mm

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More Product Details

Catalog Number

5071-257

Brand Name

NA

Version/Model Number

5071-257

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

Yes

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

GFA

Product Code Name

BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Device Record Status

Public Device Record Key

df139061-c78f-425a-9022-d8ec9732ec80

Public Version Date

January 22, 2021

Public Version Number

4

DI Record Publish Date

April 20, 2017

Additional Identifiers

Package DI Number

30845854046030

Quantity per Package

5

Contains DI Package

20845854046033

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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