DEVICE: NA (04055207011751)

Device Identifier (DI) Information

NA
2012901
In Commercial Distribution
2012.901
Richard Wolf GmbH
04055207011751
GS1

1
315304071 *Terms of Use
SECRETION COLLECTING BOTTLE for Roller suction pump 2207001, 165mm, 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
Suction system canister, reusable A cylindrical sealable container typically made of hard plastic materials used as a component of a suction system, or other system that utilizes suction, and which is designed for the collection of aspirated waste materials (e.g., blood, bodily fluids, rinsing fluids, laser plume evacuation gas) and/or body tissue intended for diagnostic/therapeutic purposes (e.g., histological analysis, autologous fat tissue transfer) from a site of operation. This device is typically used in conjunction with a dedicated disposable liner that confines and stores the contaminated waste, and may be used singularly or in a connected series to provide greater capacity. 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 [?]
K011911 000
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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

a96e7d90-f2aa-42e5-862d-5d1d6f0b2aa8
July 06, 2018
3
September 27, 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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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