DEVICE: UtahBall (H671DBL5110)
Device Identifier (DI) Information
UtahBall
Ball Electrode
In Commercial Distribution
DBL-511
UTAH MEDICAL PRODUCTS, INC.
Ball Electrode
In Commercial Distribution
DBL-511
UTAH MEDICAL PRODUCTS, INC.
Electrosurgical Electrode, 5mm Ball, 11cm Shaft
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 |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 11 Centimeter |
Outer Diameter: 5 Millimeter |
Device Record Status
1ec37ede-c6d9-488d-beec-c5971548e565
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 |
---|---|---|---|---|---|
H671DBL5112 | 10 | H671DBL5111 | In Commercial Distribution | Overpack | |
H671DBL5111 | 10 | H671DBL5110 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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