Coblation

Basic Information

• Brand Name: Coblation
• Primary DI: 00817470004182
• Version / Model: SIP001-00
• Catalog Number: SIP001-00
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-21
• Public Version: 5
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: af5df2d7-f1bd-44a0-ad63-5665c6094ea8

Device Description

IRRIGATION PUMP CONTROLLER (120V)

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: Yes
• 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
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41643	Surgical irrigation/aspiration system pump	A mains electricity (AC-powered) device used to generate positive and/or negative pressures as part of an irrigation/aspiration system used during a general surgical procedure to intermittently or continuously irrigate and/or aspirate body cavities and wounds. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817470004182	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080482	000