PerFect TCS

GUDID D661S6010A0

8 Sterilizable Electrode Sheaths

COLTENE/WHALEDENT INC

Electrosurgical system generator

• Primary Device ID: D661S6010A0
• NIH Device Record Key: a2dc979c-2503-494f-b374-92d5831e61f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerFect TCS
• Version Model Number: S6010A
• 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	D661S6010A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071632

FDA Product Code

• EKZ: Unit, Electrosurgical, And Accessories, Dental

Sterilization

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

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

[D661S6010A0]

Moist Heat or Steam Sterilization

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