DEVICE: CryoDose H (00856331006088)
Device Identifier (DI) Information
CryoDose H
170375
In Commercial Distribution
170375
NUANCE MEDICAL, LLC
170375
In Commercial Distribution
170375
NUANCE MEDICAL, LLC
CryoDose H 1 kit w/ 2 canisters, 30/ 2mm buds, 40/ 5mm buds
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
Yes | |
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 [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: do not store near direct heat source |
Storage Environment Temperature: less than 120 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 88 Milliliter |
Device Record Status
44980a13-0a3c-4af4-bd79-acdb9f02900a
April 07, 2021
3
October 03, 2016
April 07, 2021
3
October 03, 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
[?]
+1(760)585-4849
0
george@cryodose.com
george@cryodose.com