DEVICE: ERBE (04050147000261)

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Device Identifier (DI) Information

ERBE
10150-000
10150-000
Erbe Elektromedizin GmbH
04050147000261
GS1
1
ERBEJET® 2 Hydrosurgical Unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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
Water jet knife system generator A mains electricity (AC-powered) device that is a component of a water jet knife system and that generates and regulates a stream of high-pressure water to cut/dissect soft tissues, leaving hard/elastic tissues intact. The pressurized water (typically sterile saline) is delivered to the surgical site via a dedicated handpiece. The operator will typically regulate the stream of water for cutting with a foot-switch connected to the generator.
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FDA Product Code

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Product Code Product Code Name
FQH LAVAGE, JET
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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
Handling Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between -25 and 50 Degrees Celsius
Special Storage Condition, Specify: Keep away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between -25 and 50 Degrees Celsius
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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 22, 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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