DEVICE: ERBE (04050147000193)

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Device Identifier (DI) Information

ERBE
10134-000
10134-000
Erbe Elektromedizin GmbH
04050147000193
GS1
1
APC 2 (for VIO®) Argon Plasma Coagulation Unit
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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
Argon-enhanced electrosurgical system gas delivery unit A device designed to deliver argon (Ar) gas from an Ar gas source to an argon-enhanced electrosurgical system. It is typically incorporated into a trolley (cart) and is connected to the electrosurgical diathermy generator, enabling a single control for the system. The argon gas is delivered through an appropriate handpiece and active electrode (not included) to minimize tissue charring and enhance coagulation at and around the site of operation.
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FDA Product Code

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Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & 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: Keep away from heat and direct sunlight
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
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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
September 13, 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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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4970717550
info@erbe-med.com
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