UtahLoop - Electrosurgical Loop Electrode, 20mm Wide X 15mm - UTAH MEDICAL PRODUCTS, INC.

Duns Number:094651270

Device Description: Electrosurgical Loop Electrode, 20mm Wide X 15mm Deep, Round Loop, 11cm Shaft Length, with Electrosurgical Loop Electrode, 20mm Wide X 15mm Deep, Round Loop, 11cm Shaft Length, with Safe-T-Gauge

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More Product Details

Catalog Number

DLP-L11

Brand Name

UtahLoop

Version/Model Number

LETZ Electrode

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"

Yes

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

K951032,K905263,K905263,K951032,K951032,K905263

Product Code Details

Product Code

GEI

Product Code Name

Electrosurgical, Cutting & Coagulation & Accessories

Device Record Status

Public Device Record Key

6eb3ef1d-816a-4a6b-8861-86cd114b2ae6

Public Version Date

December 18, 2019

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H671DLPL112

Quantity per Package

10

Contains DI Package

H671DLPL111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack

"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