StarBurst - RITA StarBurst MRI Semi-Flex Electrosurgical - NAVILYST MEDICAL, INC.

Duns Number:809699023

Device Description: RITA StarBurst MRI Semi-Flex Electrosurgical Device

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More Product Details

Catalog Number

-

Brand Name

StarBurst

Version/Model Number

700-102615

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K992693

Product Code Details

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Device Record Status

Public Device Record Key

c85d8d8c-a3fe-4b9b-baa3-4f09e8b63c9d

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NAVILYST MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 71
2 A medical device with a moderate to high risk that requires special controls. 1641