Rev360

Basic Information

• Brand Name: Rev360
• Primary DI: 07613327055597
• Version / Model: 0504990800
• Catalog Number: 0504-990-800
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 187502109
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-09-04
• Public Version Status: Update
• Public Device Record Key: 5c63b034-8f60-41ac-88c4-0da3840cd18d
• Distribution End Date: 2023-09-02

Device Description

[Collings Knife Electrode, 22 Fr., Only for use with Stryker Resectoscopes, Do not use if package is damaged]

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
FAJ	Cystoscope and accessories, flexible/rigid	Gastroenterology, Urology	876.1500	2
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL	Gastroenterology, Urology	876.4300	2
KQT	Evacuator, gastro-urology	Gastroenterology, Urology	876.4370	2
HIH	HYSTEROSCOPE (AND ACCESSORIES)	Obstetrics/Gynecology	884.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327055598	GS1	pack	6	Not in Commercial Distribution	2023-09-02
Primary	07613327055597	GS1

Customer Contacts

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