PerFect TCS

GUDID D661S6011A0

Two 45º Coag Small Ball Electrode Sheaths

COLTENE/WHALEDENT INC

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: D661S6011A0
• NIH Device Record Key: ed0ead5a-01fc-4f69-9792-ec984d1bc0e3
• Commercial Distribution Discontinuation: 2016-06-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PerFect TCS
• Version Model Number: S6011A
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com
• Phone: 3309168800
• Email: info.us@coltene.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D661500074750 [Direct Marking]
HIBCC	D661S6011A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071632

FDA Product Code

• EKZ: Unit, Electrosurgical, And Accessories, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-04-04
• Device Publish Date: 2016-06-16

On-Brand Devices [PerFect TCS]

• D661S8FSRK0: Tissue Contouring System Footswitch
• D661S81150: Tissue Contouring System, 115V
• D661S7010A0: 3 Sterilizable Electrode Sheaths
• D661S70010: Hand Piece Holder
• D661S6018A0: Two 90º AP 1 1/2 Electrode Sheaths
• D661S6017A0: Two 45º Diamond Loop Electrode Sheaths
• D661S6016A0: Two Straight Long Loop Electrode Sheaths
• D661S6015A0: Two 45º Long Loop Electrode Sheaths
• D661S6014A0: Two Straight Round Loop Electrode Sheaths
• D661S6013A0: Two 45º Tapered Knife Electrode Sheaths
• D661S6012A0: Two 45º Straight Knife Electrode Sheaths
• D661S6011A0: Two 45º Coag Small Ball Electrode Sheaths
• D661S6010A0: 8 Sterilizable Electrode Sheaths
• D661S6008CE0: Cord Assembly
• D661S6008A0: Cord Assembly - R/A Connector
• D661S6007A0: Cord Assembly - Mark I, II & S-240 Units
• D661S6005A0: Cord Assembly - Straight Connector
• D661S6000A1: 8 Sterilizable Electrodes and Cord Assembly
• D661S2130: Tissue Contouring System Dispersive Electrode