Neck Phantom - Neck Phantom, Thyroid Uptake - BIODEX MEDICAL SYSTEMS, INC.

Duns Number:043833813

Device Description: Neck Phantom, Thyroid Uptake

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More Product Details

Catalog Number

043-365

Brand Name

Neck Phantom

Version/Model Number

043-365

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

-

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

IYP

Product Code Name

Phantom, Anthropomorphic, Nuclear

Device Record Status

Public Device Record Key

c906086e-96a1-48b7-90e5-713cca3a691a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIODEX MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 193
2 A medical device with a moderate to high risk that requires special controls. 52