COMFOR SHLDR IMMOB STRAIGHT UNIV - Bird & Cronin, LLC

Duns Number:045975349

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More Product Details

Catalog Number

-

Brand Name

COMFOR SHLDR IMMOB STRAIGHT UNIV

Version/Model Number

08140470

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

Yes

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

IQI

Product Code Name

Orthosis, Limb Brace

Device Record Status

Public Device Record Key

2a07c49a-bc40-4a0f-86e0-be07e4e521aa

Public Version Date

August 29, 2022

Public Version Number

1

DI Record Publish Date

August 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIRD & CRONIN, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2022