DEVICE: E-LINE (04055207028216)

Device Identifier (DI) Information

E-LINE
86770145
In Commercial Distribution
8677.0145
Richard Wolf GmbH
04055207028216
GS1

1
315304071 *Terms of Use
SHEATH RESECTOSCOPE 11.5FR color code yellow, SL 105mm, oval, slanted distal end, compatible with attachment 8677254, working element 8677224, and telescopes Ø 2.7mm, 0°, with irrigation stopcock, quick-lock, 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
Hydrogen Peroxide
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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: 3.83333333333 Millimeter
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Device Record Status

d5572998-59fc-4e9b-babc-c44c38706aa3
September 21, 2018
5
September 26, 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)

[?]
Yes
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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