DEVICE: ERBE (04050147000599)

Device Identifier (DI) Information

ERBE
20132-043
Not in Commercial Distribution
20132-043
Erbe Elektromedizin GmbH
04050147000599
GS1
September 22, 2018
1
316116623 *Terms of Use
APC handle with 2 buttons cut/coag; cable 3m
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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 handpiece A hand-held holder for a detachable rigid electrode intended to be used as part of an argon-enhanced electrosurgical system to enable both electrical connection and argon gas supply from the system generator/gas delivery unit to the electrode. It typically includes controls and an attached cable, and is designed to allow the surgeon controlled manipulation of the electrode, which is not included. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K003462 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
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
No Device Sizes
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Device Record Status

ab62c154-7217-4629-8818-6890a4eb7782
September 24, 2018
4
September 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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