DEVICE: SHARK (04055207019733)

Device Identifier (DI) Information

SHARK
8676361
In Commercial Distribution
8676361
Richard Wolf GmbH
04055207019733
GS1

1
315304071 *Terms of Use
IRRIGATION ADAPTOR RESECTOSCOPE 24/26FR rotatable, intermittent flushing, compatible with Shark sheath 8676324 and 8676326, with Luer connection, reusable
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rigid endoscope sheath, reusable A component of a rigid endoscope assembly designed as a tube through which an endoscope and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
FJL RESECTOSCOPE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K062720 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

ab1d224d-f6c7-494a-abfa-15b334a100c7
July 24, 2018
4
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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
No
No CLOSE

Customer Contact

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