DEVICE: ERBE (04050147001022)
Device Identifier (DI) Information
ERBE
20132-129
In Commercial Distribution
20132-129
Erbe Elektromedizin GmbH
20132-129
In Commercial Distribution
20132-129
Erbe Elektromedizin GmbH
Protective sleeve for ENT APC side fire applicators
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? |
---|---|---|---|---|
61879 | Inert gas-enhanced open-surgery electrosurgical electrode, reusable |
A rigid, invasive, distal component of an inert gas-enhanced electrosurgical system intended to be connected to a handpiece (not included) to deliver electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] directly to tissues for cutting/coagulation during open surgery. It is typically designed as a coaxial arrangement of a monopolar electrode within a gas delivery sleeve; it requires a patient contact return electrode to complete the circuit. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K963189 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Special Storage Condition, Specify: Keep dry |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d9a56b75-b346-4945-80ea-246a7aab0e6a
April 04, 2023
4
September 16, 2016
April 04, 2023
4
September 16, 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 |
---|---|---|---|---|---|
04050147020474 | 10 | 04050147001022 | In Commercial Distribution | Level: 1 |
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
[?]
+4970717550
info@erbe-med.com
info@erbe-med.com