V. Mueller - POPPEN INTERVERTBRAL DISC RONGEUR STRAIGHT, CUP - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: POPPEN INTERVERTBRAL DISC RONGEUR STRAIGHT, CUP JAWS 4X7MM SHAFT LENGTH 6" (15.2CM)

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More Product Details

Catalog Number

NL6131

Brand Name

V. Mueller

Version/Model Number

NL6131

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

HAE

Product Code Name

RONGEUR, MANUAL

Device Record Status

Public Device Record Key

e42c298c-7491-41f4-a551-cedb935317c9

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

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