DEVICE: Freezpen (B386CLN2O8GBOX1)

Device Identifier (DI) Information

Freezpen
8g N2O cartridges for Freezpen
In Commercial Distribution
CL-N2O-8G-BOX
H & O Equipments SA
B386CLN2O8GBOX1
HIBCC

15
370212933 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Nitrous oxide cartridge A small, non-sterile, sealed cylinder containing pressurized nitrous oxide (N2O) gas intended to be inserted into a parent device (e.g., cryosurgical system) where the cylinder is perforated to release the gas, which typically serves as a refrigerant (Joule-Thomson effect). This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
GEH Unit, Cryosurgical, Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K024009 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

38734934-6f34-49e5-856d-21864d276097
July 06, 2018
3
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B386CLN2O8GCARTON2 16 B386CLN2O8GBOX1 In Commercial Distribution
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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

[?]
Unit of Use DI Number: B386CLN2O8GBOX0 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
888-2482838
info@clinic6.com
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