PerFect TCS

GUDID D661S6010A0

8 Sterilizable Electrode Sheaths

COLTENE/WHALEDENT INC

Electrosurgical system generator
Primary Device IDD661S6010A0
NIH Device Record Keya2dc979c-2503-494f-b374-92d5831e61f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePerFect TCS
Version Model NumberS6010A
Company DUNS622185718
Company NameCOLTENE/WHALEDENT INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com
Phone3309168800
Emailinfo.us@coltene.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD661S6010A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKZUnit, Electrosurgical, And Accessories, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-04-04
Device Publish Date2016-06-16

On-Brand Devices [PerFect TCS]

D661S8FSRK0Tissue Contouring System Footswitch
D661S81150Tissue Contouring System, 115V
D661S7010A03 Sterilizable Electrode Sheaths
D661S70010Hand Piece Holder
D661S6018A0Two 90º AP 1 1/2 Electrode Sheaths
D661S6017A0Two 45º Diamond Loop Electrode Sheaths
D661S6016A0Two Straight Long Loop Electrode Sheaths
D661S6015A0Two 45º Long Loop Electrode Sheaths
D661S6014A0Two Straight Round Loop Electrode Sheaths
D661S6013A0Two 45º Tapered Knife Electrode Sheaths
D661S6012A0Two 45º Straight Knife Electrode Sheaths
D661S6011A0Two 45º Coag Small Ball Electrode Sheaths
D661S6010A08 Sterilizable Electrode Sheaths
D661S6008CE0Cord Assembly
D661S6008A0Cord Assembly - R/A Connector
D661S6007A0Cord Assembly - Mark I, II & S-240 Units
D661S6005A0Cord Assembly - Straight Connector
D661S6000A18 Sterilizable Electrodes and Cord Assembly
D661S2130Tissue Contouring System Dispersive Electrode

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