DEVICE: E-LINE (04055207019344)

Device Identifier (DI) Information

E-LINE
8670061
In Commercial Distribution
8670.061
Richard Wolf GmbH
04055207019344
GS1

1
315304071 *Terms of Use
OUTER SHEATH FOR URETHROTOME 19.5FR SL 172mm, oval, lateral opening, continuous irrigation, compatible with sheath 8670011, 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
EZO Urethrotome
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K000905 000
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Sterilization

No
Yes
Sterilization Method [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
Ethylene Oxide
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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
Outer Diameter: 6.5 Millimeter
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Device Record Status

cb70bd28-864c-4198-8d79-94db6647d5ab
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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