DEVICE: NA (00852073002234)
Device Identifier (DI) Information
NA
Loop Electrode
In Commercial Distribution
LE-01-104
C R I
Loop Electrode
In Commercial Distribution
LE-01-104
C R I
Square Loop,
Loop Size: 10mm x 4mm
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HGI | Electrocautery, Gynecologic (And Accessories) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K022593 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 13 Centimeter |
Device Record Status
43d7a744-c987-4b4c-94a6-bd2040b1f9de
May 27, 2019
4
October 10, 2016
May 27, 2019
4
October 10, 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 |
---|---|---|---|---|---|
10852073002231 | 5 | 00852073002234 | 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) 556-0349
Sales@ThomasMedical.com
Sales@ThomasMedical.com