DEVICE: ERBE (04050147005136)
Device Identifier (DI) Information
ERBE
20193-071
In Commercial Distribution
20193-071
Erbe Elektromedizin GmbH
20193-071
In Commercial Distribution
20193-071
Erbe Elektromedizin GmbH
ERBE NESSY®Plate 70 split; 72cm²
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
58494 | Electrosurgical return electrode, single-use |
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use 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 [?] |
---|---|
K972269 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry |
Storage Environment Temperature: more than 0 Degrees Celsius |
Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Area/Surface Area: 72.000 Square centimeter |
Device Record Status
851acdf9-759a-47a8-a1fd-9bce1a29d188
June 05, 2020
5
December 16, 2016
June 05, 2020
5
December 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 |
---|---|---|---|---|---|
04050147015494 | 50 | 04050147005136 | In Commercial Distribution | Level: 1 | |
04050147017467 | 4 | 04050147015494 | In Commercial Distribution | Level: 2 |
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