DEVICE: E-LINE (04055207045565)
Device Identifier (DI) Information
E-LINE
86520445
In Commercial Distribution
8652.0445
Richard Wolf GmbH
86520445
In Commercial Distribution
8652.0445
Richard Wolf GmbH
SHEATH FOR CYSTOSCOPE 21FR color code blue, SL 209mm, oval, slanted distal end, capacity for instruments up to 10Fr or 2x 6Fr, compatible with attachments 8652254, 8652264, 8652.284, and telescopes Ø 4mm, with 2 flushing ports, quick-lock, reusable
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FBO | CYSTOURETHROSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Hydrogen Peroxide |
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 7 Millimeter |
Device Record Status
2533a6dc-131b-4941-9a9f-f4869bab58af
March 29, 2018
2
September 26, 2016
March 29, 2018
2
September 26, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com