V. Mueller - V. Mueller CHERRY SPONGE X-RAY DETECTABLE 1/2IN - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: V. Mueller CHERRY SPONGE X-RAY DETECTABLE 1/2IN (13MM)

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More Product Details

Catalog Number

23275-480

Brand Name

V. Mueller

Version/Model Number

23275-480

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 15, 2021

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"

Yes

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

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Device Record Status

Public Device Record Key

674a7f11-19e4-4a86-ace5-bea921af3b02

Public Version Date

March 04, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2018

Additional Identifiers

Package DI Number

70885403302918

Quantity per Package

5

Contains DI Package

10885403302916

Package Discontinue Date

February 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Pack

"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