E-LINE

Basic Information

• Brand Name: E-LINE
• Primary DI: 04055207049075
• Version / Model: 48423025
• Catalog Number: 48423.025
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2017-06-28
• Public Version: 5
• Public Version Date: 2021-04-28
• Public Version Status: Update
• Public Device Record Key: 48db5faf-714a-437b-aa52-b33bb1955652

Device Description

COAG ELECTRODE MONO 22-25FR 12/30° for resectoscopes, telescope Ø 4mm, for sheaths, intermittent/continuous irrigation, 22/24/24.5/25.5/26/27, Fr, electrode shape: roller, fork color transparent, stem color red, PACK=5 PCS, for E-Line resectoscope, sterile, for single use

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact 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 ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207049075	GS1
Unit of Use	04055207050217	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius