DEVICE: CareOne (00041520039149)

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Device Identifier (DI) Information

CareOne
773514
773514
Ahold U.S.A., Inc.
00041520039149
GS1
1
Wart Freezer One Step Wart Remover
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
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
Wart-removal cryogenic kit A collection of devices designed to apply cold from a liquid/gaseous refrigerant (cryogen) to a common or plantar (sole of foot) wart for its removal. The collection typically includes a pressurized cannister with a cryogenic mixture (e.g., liquid dimethyl ether and propane), disposable applicators, a reusable activator that releases the cryogen into the applicators, and cushions; it may also include a liquid wart remover (e.g., salicylic acid) for post-cryo treatment. It is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.
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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
Special Storage Condition, Specify: 20-25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Height: 155 Millimeter
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Device Status

In Commercial Distribution
August 31, 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
10041520939149 6 00041520039149 2016-10-24 Not in Commercial Distribution Case
10041520039146 6 00041520039149 In Commercial Distribution case
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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

[?]
941-378-6658
fjuliao@asocorp.com
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