BRYDAN MEDICAL - Alum Transport W/C 18" seat width, green uph. - BRYDAN MEDICAL HOLDINGS

Duns Number:078612438

Device Description: Alum Transport W/C 18" seat width, green uph.

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More Product Details

Catalog Number

-

Brand Name

BRYDAN MEDICAL

Version/Model Number

99999

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

K973418

Product Code Details

Product Code

IOR

Product Code Name

Wheelchair, Mechanical

Device Record Status

Public Device Record Key

06770196-80de-4f93-8d50-833f8fe01ef3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 03, 2018

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