DEVICE: ERBE (04050147020252)

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Device Identifier (DI) Information

ERBE
20132-212
20132-212
Erbe Elektromedizin GmbH
04050147020252
GS1
1
APC probe 3000 A, single use OD 1.5mm / 4.5Fr; L 3m / 9.8ft
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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 endoscopic electrosurgical electrode, single-use A sterile, invasive, distal component of an argon-enhanced electrosurgical system intended to deliver electrosurgical current within a stream of argon (Ar) gas directly to tissues for cutting/coagulation/ablation during an endoscopic (including laparoscopic, arthroscopic) surgical procedure. It is a long thin device with no controls, typically designed as a coaxial arrangement of a monopolar electrode within an Ar gas delivery tube/sleeve, which requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., rigid laparoscopic electrode, flexible endoscopic probe). 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 away from heat and direct sunlight
Special Storage Condition, Specify: Keep dry
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Clinically Relevant Size

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Size Type Text
Length: 3.000 Meter
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Device Status

In Commercial Distribution
December 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
04050147015043 10 04050147020252 In Commercial Distribution Level: 1
04050147017351 10 04050147015043 In Commercial Distribution Level: 2
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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