V. Mueller - PUTTI BONE RASP DOUBLE-ENDED, W/FLAT TAPERING - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: PUTTI BONE RASP DOUBLE-ENDED, W/FLAT TAPERING BLADES, 1 BLADE CURVED ON FLAT OVERALL LENGT PUTTI BONE RASP DOUBLE-ENDED, W/FLAT TAPERING BLADES, 1 BLADE CURVED ON FLAT OVERALL LENGTH 10-1/2"(26.7CM)

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More Product Details

Catalog Number

OS4450

Brand Name

V. Mueller

Version/Model Number

OS4450

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

HTR

Product Code Name

RASP

Device Record Status

Public Device Record Key

5fb12216-a65b-4c4d-8630-2ffc3d690c93

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

September 10, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAREFUSION 2200, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 8016
2 A medical device with a moderate to high risk that requires special controls. 6223