BRYDAN MEDICAL - L/R - PR to fit 18" thru 24" width MRI green - w/ - BRYDAN MEDICAL HOLDINGS

Duns Number:078612438

Device Description: L/R - PR to fit 18" thru 24" width MRI green - w/ padded calf pad

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More Product Details

Catalog Number

-

Brand Name

BRYDAN MEDICAL

Version/Model Number

11629

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

KNO

Product Code Name

Accessories, Wheelchair

Device Record Status

Public Device Record Key

6f4221da-639e-4eac-9cf9-75fae710dec1

Public Version Date

March 29, 2018

Public Version Number

2

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