DEVICE: ERBE (04050147019737)
Device Identifier (DI) Information
ERBE
10448-004
In Commercial Distribution
10448-004
Erbe Elektromedizin GmbH
10448-004
In Commercial Distribution
10448-004
Erbe Elektromedizin GmbH
ERBOCRYO® CA Cryosurgical System, 120 V/60Hz, UL
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? |
---|---|---|---|---|
11067 | General cryosurgical system, cryogen gas, mechanical |
An assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to malignant or abnormal benign tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) and is not dedicated to ophthalmic or cardiac use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEH | UNIT, CRYOSURGICAL, ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K051509 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between -40 and 70 Degrees Celsius |
Storage Environment Temperature: between -40 and 70 Degrees Celsius |
Special Storage Condition, Specify: Keep dry |
Special Storage Condition, Specify: Keep away from heat and direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b7e34c05-b174-4520-98a3-c5e7eead25c7
April 07, 2021
4
September 10, 2016
April 07, 2021
4
September 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 |
---|---|---|---|---|---|
No Package DIs found |
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