DEVICE: ERBE (04050147005143)

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Device Record History
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Device Identifier (DI) Information
ERBE
20193-072
In Commercial Distribution
20193-072
Erbe Elektromedizin GmbH
04050147005143
GS1

1
316116623 *Terms of Use
ERBE MONOPlate 140 single; 136cm²
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58494 Electrosurgical return electrode, single-use
A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It will typically be designed with permanently attached leads. This is a single-use device.
Active false
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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 [?]
K972269 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
Storage Environment Temperature: more than 0 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Area/Surface Area: 136.000 Square centimeter
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Device Record Status
124d6559-ec33-4136-95b9-0f47471f1f55
June 05, 2020
4
December 16, 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
04050147017474 4 04050147015500 In Commercial Distribution Level: 3
04050147015500 10 04050147017696 In Commercial Distribution Level: 2
04050147017696 5 04050147005143 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)

[?]
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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