DEVICE: RESECTION MASTER (04055207019078)

Device Identifier (DI) Information

RESECTION MASTER
8659071
In Commercial Distribution
8659.071
Richard Wolf GmbH
04055207019078
GS1

1
315304071 *Terms of Use
OUTER SHEATH RESECTOSCOPE 27FR color code yellow, WL 184mm, round, distal end straight, compatible with outer sheath 8659071 for Resection Master Resectoscope 27Fr with integrated chip suction, and telescopes Ø 3.3mm, 30°, with Luer connection, E-Line quick connection, 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
Rigid endoscope sheath An endoscopic device that is a component of a rigid endoscope assembly shaped as a thin metal tube through which other endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
FJL RESECTOSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042523 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
Outer Diameter: 9 Millimeter
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Device Record Status

6e0044b2-9ba3-4a16-8f27-245ce3e915d3
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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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