Sun Nuclear BRN-SR2 Brain - GAMMEX, INC.

Duns Number:157308230

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More Product Details

Catalog Number

-

Brand Name

Sun Nuclear BRN-SR2 Brain

Version/Model Number

481

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

LHO

Product Code Name

Instrument, Quality-Assurance, Radiologic

Device Record Status

Public Device Record Key

a2917f1f-c100-4240-bb48-1ac70c51ef93

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GAMMEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 72