R82 - R82 A/S

Duns Number:308022169

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More Product Details

Catalog Number

869033-SL

Brand Name

R82

Version/Model Number

Mustang SIZE-3

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)

-

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

fdb2365b-70cd-4bb2-a4da-e82181b623f2

Public Version Date

October 20, 2022

Public Version Number

1

DI Record Publish Date

October 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"R82 A/S" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 210