THYROID SHIELD - THYROID SHIELD, TS BIB, .25MM STRATA 300, TETHER - BURLINGTON MEDICAL, LLC

Duns Number:083381202

Device Description: THYROID SHIELD, TS BIB, .25MM STRATA 300, TETHER TO BUCKLE, MAGNET, MD

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More Product Details

Catalog Number

-

Brand Name

THYROID SHIELD

Version/Model Number

U3TSBMB-MD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

IWO

Product Code Name

Apron, Protective

Device Record Status

Public Device Record Key

5cbd74f2-91ed-4660-a80a-6b88e8167688

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BURLINGTON MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12773
3 A medical device with high risk that requires premarket approval 1