BRYDAN MEDICAL - Bariatric Walkeradj height: 32' - 38-1/2 - BRYDAN MEDICAL HOLDINGS

Duns Number:078612438

Device Description: Bariatric Walkeradj height: 32' - 38-1/2

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More Product Details

Catalog Number

-

Brand Name

BRYDAN MEDICAL

Version/Model Number

12204

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

e317823a-48e1-41e9-9453-85194895d731

Public Version Date

October 05, 2018

Public Version Number

3

DI Record Publish Date

December 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BRYDAN MEDICAL HOLDINGS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 2