Primary Device ID | D661S6000A1 |
NIH Device Record Key | b8abf2b2-931b-48e0-89b9-22efbb360359 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PerFect TCS |
Version Model Number | S6000A |
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 |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com | |
Phone | 3309168800 |
info.us@coltene.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D661S6000A1 [Primary] |
EKZ | Unit, Electrosurgical, And Accessories, Dental |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2023-04-04 |
Device Publish Date | 2016-06-16 |
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 |