DEVICE: PRINCESS (04055207048979)
Device Identifier (DI) Information
PRINCESS
46531323
In Commercial Distribution
4653.1323
Richard Wolf GmbH
46531323
In Commercial Distribution
4653.1323
Richard Wolf GmbH
CUTTING ELECTRODE BIPO 24.5FR for hysteroscopy, for continuous irrigation sheaths, 24.5, Fr, loop: round, wire Ø 0.3mm, fork color transparent, stem color blue, PACK=3 PCS, for use in combination with the Princess resectoscope, sterile, for single use
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61872 | Endoscopic electrosurgical electrode, bipolar, single-use |
An invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device intended to be used in a sterile condition.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FAS | ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 5 and 30 Degrees Celsius |
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 8.16666666666 Millimeter |
Device Record Status
c0d3176c-ccee-41eb-b8c3-bdb8554ecfed
December 09, 2024
10
June 28, 2017
December 09, 2024
10
June 28, 2017
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:
04055207050118
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+497043350
info@richard-wolf.com
info@richard-wolf.com