FINESSE - Starter Kit, Including 1 ea. DLS-200, 5 ea. - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: Starter Kit, Including 1 ea. DLS-200, 5 ea. ESU-305, 1 ea. ESU-501, 15 ea. ESU-502, & 10 e Starter Kit, Including 1 ea. DLS-200, 5 ea. ESU-305, 1 ea. ESU-501, 15 ea. ESU-502, & 10 ea. ES-1179

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More Product Details

Catalog Number

FIN-800

Brand Name

FINESSE

Version/Model Number

Starter Kit

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

K123310

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

94b61bdd-af53-4b3d-a8ff-b64d2eb42ac0

Public Version Date

December 18, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UTAH MEDICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 35
2 A medical device with a moderate to high risk that requires special controls. 274