McKesson - Lightweight Rollator red aluminum frame with - MCKESSON MEDICAL-SURGICAL INC.

Duns Number:023904428

Device Description: Lightweight Rollator red aluminum frame with 6-inch wheels 29.5-38 in Handle Height

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More Product Details

Catalog Number

-

Brand Name

McKesson

Version/Model Number

146-RTL10261RD

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

ITJ

Product Code Name

Walker, Mechanical

Device Record Status

Public Device Record Key

7c6f2adc-896a-4531-9f55-39e11af6e0d8

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 19, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MCKESSON MEDICAL-SURGICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 870
2 A medical device with a moderate to high risk that requires special controls. 422
U Unclassified 44