V. Mueller - DEBAKEY ULTRA LIGHT NEEDLE HOLDER TUNGSTEN - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: DEBAKEY ULTRA LIGHT NEEDLE HOLDER TUNGSTEN CARBIDE INSERTS OVERALL LENGTH 9"(22.9CM)

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More Product Details

Catalog Number

CH2488

Brand Name

V. Mueller

Version/Model Number

CH2488

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

DWS

Product Code Name

INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Device Record Status

Public Device Record Key

a2cf62a5-8c1f-4a34-b75a-7f1fa44f25a1

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

August 09, 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