DEVICE: ERBE (04050147020092)

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Device Identifier (DI) Information

ERBE
20150-215
20150-215
Erbe Elektromedizin GmbH
04050147020092
GS1
1
HybridAPC probe OD 2.3mm; L 1.9m
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Argon-enhanced endoscopic electrosurgical electrode/submucosal lift needle A sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of argon (Ar) gas (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of the diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by argon plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to the appropriate parent devices (i.e., argon-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include any controls. This is a single-use device.
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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

Yes
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 dry
Special Storage Condition, Specify: Keep away from heat and direct sunlight
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Clinically Relevant Size

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Size Type Text
Length: 1.900 Meter
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Device Status

In Commercial Distribution
September 16, 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
04050147020108 5 04050147020092 In Commercial Distribution Level: 1
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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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Yes
No
Yes
No
No CLOSE

Customer Contact

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