DEVICE: E-LINE (04055207010952)
Device Identifier (DI) Information
E-LINE
865467
In Commercial Distribution
8654.67
Richard Wolf GmbH
865467
In Commercial Distribution
8654.67
Richard Wolf GmbH
OBTURATOR RESECTOSCOPE 24FR color code yellow, WL 130mm, round, flexible distal end, 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 [?] |
---|
Moist Heat or Steam Sterilization |
Ethylene Oxide |
Hydrogen Peroxide |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 8 Millimeter |
Device Record Status
66242f5f-5578-4bb8-8bc3-70d5ffdf9a85
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