DEVICE: ERBE (04050147000193)
Device Identifier (DI) Information
ERBE
10134-000
In Commercial Distribution
10134-000
Erbe Elektromedizin GmbH
10134-000
In Commercial Distribution
10134-000
Erbe Elektromedizin GmbH
APC 2 (for VIO®) Argon Plasma Coagulation Unit
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
36154 | Argon-enhanced electrosurgical system gas delivery unit |
A device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K024047 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Handling Environment Temperature: between -40 and 70 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
f8a67b91-0cae-4d38-bee0-acdc817948d8
July 06, 2018
3
September 13, 2016
July 06, 2018
3
September 13, 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 |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
+4970717550
info@erbe-med.com
info@erbe-med.com