C-LETZ DCE-125

GUDID H671DCE1252

Conization Electrode, 9mm Radius, 13mm Deep

UTAH MEDICAL PRODUCTS, INC.

Open-surgery electrosurgical electrode, monopolar, single-use
Primary Device IDH671DCE1252
NIH Device Record Key910aa86a-acab-4dd9-a001-5b7b0e470425
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-LETZ
Version Model NumberContoured LETZ Electrode
Catalog NumberDCE-125
Company DUNS094651270
Company NameUTAH MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-533-4984
Emailcustomer@utahmed.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCH671DCE1250 [Primary]
HIBCCH671DCE1251 [Package]
Contains: H671DCE1250
Package: Box [10 Units]
In Commercial Distribution
HIBCCH671DCE1252 [Package]
Contains: H671DCE1251
Package: Overpack [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-12-18
Device Publish Date2016-09-23

On-Brand Devices [C-LETZ]

H671DCE1252Conization Electrode, 9mm Radius, 13mm Deep
H671DCE1202Conization Electrode, 12mm Radius, 10mm Deep
H671DCE1152Conization Electrode, 11mm Radius, 18mm Deep
H671DCE1102Conization Electrode, 15mm Radius, 23mm Deep

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