DEVICE: BodyFX (07290016633085)

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Device Identifier (DI) Information

BodyFX
AS600874A
AS600874A
INMODE M.D LTD
07290016633085
GS1
1
BodyFX
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
Radio-frequency skin surface treatment system An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin?s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.
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FDA Product Code

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Product Code Product Code Name
NUV Massager, Vacuum, Light Induced Heating
ISA Massager, Therapeutic, Electric
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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: between -20 and 65 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 25, 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)

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

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
1-887-367-4556
contact@inmode.com
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