| Primary Device ID | D661S6005A0 |
| NIH Device Record Key | 048a20c2-926b-4084-8d1b-048de9af0ce7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PerFect TCS |
| Version Model Number | S6005A |
| 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 | D661S6005A0 [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 |