V. Mueller - SHADOW-LINE OFFSET LUMBAR RETRACTOR SYSTEM - CAREFUSION 2200, INC

Duns Number:832696038

Device Description: SHADOW-LINE OFFSET LUMBAR RETRACTOR SYSTEM STORAGE CASE

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More Product Details

Catalog Number

Y-0171

Brand Name

V. Mueller

Version/Model Number

Y-0171

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 18, 2019

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

0de2f036-5a76-4f5e-97e1-6a5fb5eb637a

Public Version Date

July 08, 2021

Public Version Number

4

DI Record Publish Date

June 17, 2019

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