N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885556609705
• Version / Model: 7209361F
• Catalog Number: 7209361F
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 8923a57b-ed5c-4b91-8b62-16fc75872fa0
• Distribution End Date: 2022-03-17

Device Description

RFB CCU PAL 325Z DV

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, general & plastic surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36739	Camera control unit	A mains electricity (AC-powered) unit intended to be used to remotely steer a camera's movements and adjustments (e.g., a miniaturized camera) in a clinical setting. It is typically situated outside the field of operation and can be adjusted upon instructions from the surgeon/operator, or it may be automated to a certain degree. Some remote control units may have extensive functions and may supply the camera with electric current and adjustments such as light intensity, colour control, automatic exposure, and automatic flash. Those types used in ophthalmology may operate the raise/lower function of the ophthalmic instrument table upon which the camera is situated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556609705	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K972471	000