CODMAN - CODMAN Wire Pass Drill Disposable - CODMAN & SHURTLEFF, INC.

Duns Number:607846297

Device Description: CODMAN Wire Pass Drill Disposable

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More Product Details

Catalog Number

261247

Brand Name

CODMAN

Version/Model Number

26-1247

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

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

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Device Record Status

Public Device Record Key

0d151b27-5989-42cf-85f0-783345b4dc21

Public Version Date

September 01, 2022

Public Version Number

4

DI Record Publish Date

June 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CODMAN & SHURTLEFF, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 1054
3 A medical device with high risk that requires premarket approval 11