ArcCHECK Cavity Plug - Accessory to Models 1220 ArcCHECK and 1220-MR - SUN NUCLEAR CORP.

Duns Number:122240021

Device Description: Accessory to Models 1220 ArcCHECK and 1220-MR ArcCHECK-MR.

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More Product Details

Catalog Number

12200001Z

Brand Name

ArcCHECK Cavity Plug

Version/Model Number

12200001Z

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

d5c5ec64-235d-4bc5-b4b5-5f3c780fe6a9

Public Version Date

April 17, 2019

Public Version Number

5

DI Record Publish Date

January 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SUN NUCLEAR CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 112