DEVICE: E-LINE (04055207010037)
Device Identifier (DI) Information
E-LINE
841511
In Commercial Distribution
8415.11
Richard Wolf GmbH
841511
In Commercial Distribution
8415.11
Richard Wolf GmbH
VIEWING OBTURATOR RESECTOSCOPE 22FR color code green, WL 232mm, rounded distal end, compatible with E-Line sheaths 8654064, 8663064, 8655344, 8655144, and telescopes Ø 4mm, 0°/12°/30°, bayonet-cap, 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 obturator | An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FJL | RESECTOSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
Ethylene Oxide |
Hydrogen Peroxide |
Moist Heat or Steam Sterilization |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 7.33333333333 Millimeter |
Device Record Status
c1c9bc21-e2d3-499d-9ffc-564edaba4aca
September 21, 2018
4
September 26, 2016
September 21, 2018
4
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