DEVICE: E-LINE (04055207027912)

Device Identifier (DI) Information

E-LINE
86500545
In Commercial Distribution
8650.0545
Richard Wolf GmbH
04055207027912
GS1

1
315304071 *Terms of Use
SHEATH FOR CYSTOSCOPE 23FR color code white, SL 231mm, oval, slanted distal end, capacity for instruments up to 12Fr or 2x7Fr, compatible with attachments 8650254, 8650264, 8650.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, reusable
CLOSE

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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FDC RESECTOSCOPE, WORKING ELEMENT
CLOSE

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
Hydrogen Peroxide
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 7.66666666666 Millimeter
CLOSE

Device Record Status

2a8ffba6-5be7-4e4e-b5a6-785b2a8b4eaf
March 29, 2018
2
September 26, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

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