DEVICE: Helium Supply Line (8 m), bar (00859019006035)
Device Identifier (DI) Information
Helium Supply Line (8 m), bar
FPRCH6101
Not in Commercial Distribution
FPRCH6101
GALIL MEDICAL INC.
FPRCH6101
Not in Commercial Distribution
FPRCH6101
GALIL MEDICAL INC.
Cryoablation System Accessory
Device Characteristics
MR Unsafe | |
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
45738 | General cryosurgical system, cryogen gas, electronic |
An assembly of electrically-powered 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 destruction and removal. The system includes an electronic control unit with LCD display to control the flow of cryogen from an attached cylinder, which might monitor skin temperature, and cryogen-cooled probes. It is intended for e.g., oncological, dermatological, oral, gynaecological, urological, proctological, or general surgical applications, however it is not dedicated to ophthalmic or cardiac surgery.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEH | Unit, Cryosurgical, Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in Visual-ICE Cryoablation System Storage Compartment |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 8 Meter |
Device Record Status
ad2a0141-8869-4030-a43f-a94dcc53b497
April 08, 2022
7
August 15, 2016
April 08, 2022
7
August 15, 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
[?]
651-287-5000
galil.cst@btgplc.com
galil.cst@btgplc.com