DEVICE: E-LINE (04055207027899)

Device Identifier (DI) Information

E-LINE
86500445
In Commercial Distribution
8650.0445
Richard Wolf GmbH
04055207027899
GS1

1
315304071 *Terms of Use
SHEATH FOR CYSTOSCOPE 21FR color code blue, SL 231mm, oval, slanted distal end, capacity for instruments up to 10Fr or 2x 6Fr, compatible with attachments 8650254, 8650264, 8650.284, and telescopes Ø 4mm, 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 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
FDC RESECTOSCOPE, WORKING ELEMENT
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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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 7 Millimeter
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Device Record Status

fee373a1-b371-4b6c-9dd4-fcecdf4cc91e
July 06, 2018
3
September 26, 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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