V. Mueller - V. Mueller ROUND STICK SPONGE X-RAY DETECTABLE - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: V. Mueller ROUND STICK SPONGE X-RAY DETECTABLE 1IN (25MM)

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

23275-740

Brand Name

V. Mueller

Version/Model Number

23275-740

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

d49aef1e-79ea-4656-8b8b-e2a25f247362

Public Version Date

March 04, 2022

Public Version Number

2

DI Record Publish Date

July 12, 2018

Additional Identifiers

Package DI Number

50885403067790

Quantity per Package

25

Contains DI Package

70885403067794

Package Discontinue Date

February 15, 2021

Package Status

Not in Commercial Distribution

Package Type

Case

"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