DEVICE: CryoDose (00856331006033)

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Device Identifier (DI) Information

CryoDose
1103
1103
NUANCE MEDICAL, LLC
00856331006033
GS1
1
CryoDose 162 mL (175 g) Reusable Treatment Kit (80 Buds)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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 a target 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) to remove malignant or abnormal benign tissues.
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FDA Product Code

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Product Code Product Code Name
GEH UNIT, CRYOSURGICAL, ACCESSORIES
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 120 Degrees Fahrenheit
Special Storage Condition, Specify: do not store near direct heat source
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Clinically Relevant Size

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Size Type Text
Total Volume: 162 Milliliter
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Device Status

In Commercial Distribution
October 03, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1(760)585-4849 0
george@cryodose.com
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