DEVICE: E-LINE (04055207018927)

Device Identifier (DI) Information

E-LINE
8655144
In Commercial Distribution
8655.144
Richard Wolf GmbH
04055207018927
GS1

1
315304071 *Terms of Use
INTERNAL SHEATH RESECTOSCOPE 22.5FR color code green, SL 200, round, rotatable irrigation ring, slanted distal end, ceramic, continuous irrigation, compatible with outer sheath 8655134, and telescopes Ø 4mm, 12°/30°, with 2 flushing ports, 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

[?]

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

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

FDA Premarket Submission Number [?] Supplement Number [?]
K980302 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: 7.5 Millimeter
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Device Record Status

79d56632-b9b7-4a53-b54a-26dadb4b3b53
July 24, 2018
4
September 28, 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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