DEVICE: NA (04055207008669)

Device Identifier (DI) Information

NA
203012
In Commercial Distribution
2030.12
Richard Wolf GmbH
04055207008669
GS1

1
315304071 *Terms of Use
FOOTSWITCH 1 PEDAL for Ultrasound generator 2271001, reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Foot-switch, electrical An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
FFK Lithotriptor, electro-hydraulic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011065 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Hydrogen Peroxide
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

4a50c2dd-9858-44c9-a1ce-c047441155d2
July 06, 2018
3
September 23, 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

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
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