DEVICE: C-LETZ (H671DCE1250)
Device Identifier (DI) Information
C-LETZ
Contoured LETZ Electrode
In Commercial Distribution
DCE-125
UTAH MEDICAL PRODUCTS, INC.
Contoured LETZ Electrode
In Commercial Distribution
DCE-125
UTAH MEDICAL PRODUCTS, INC.
Conization Electrode, 9mm Radius, 13mm Deep
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61874 | Open-surgery electrosurgical electrode, monopolar, single-use |
An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
HGI | Electrocautery, Gynecologic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K905263 | 000 |
K951032 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Depth: 13 Millimeter |
Device Size Text, specify: Excision Radius - 9 mm |
Device Record Status
910aa86a-acab-4dd9-a001-5b7b0e470425
December 18, 2019
5
September 23, 2016
December 18, 2019
5
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
H671DCE1252 | 10 | H671DCE1251 | In Commercial Distribution | Overpack | |
H671DCE1251 | 10 | H671DCE1250 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-533-4984
customer@utahmed.com
customer@utahmed.com