| Primary Device ID | 00810000520909 |
| NIH Device Record Key | afdd2f9d-71cb-4416-8475-3b7d47510240 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TurboSENSOR +™ |
| Version Model Number | D722 |
| Catalog Number | D722 |
| Company DUNS | 009900424 |
| Company Name | PARKELL, 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 | true |
| OTC Over-The-Counter | false |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Special Storage Condition, Specify | Between 0 and 0 *DO NOT USE DRY HEAT OR CHEMCLAVE THE HANDPIECE |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810000520909 [Primary] |
| ELC | Scaler, Ultrasonic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
[00810000520909]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-30 |
| Device Publish Date | 2023-10-20 |
| 00810000521128 | POWER ADAPTER LINE CORD for D735 |
| 00810000521074 | TurboSENSOR +™ Detachable 30K (LOANER) |
| 00810000521067 | TurboSENSOR +™ Detachable 30K (Lilac) |
| 00810000521050 | TurboSENSOR +™ Detachable 30K (Tangerine) |
| 00810000521043 | TurboSENSOR +™ Detachable 30K (Midnight Blue) |
| 00810000521036 | TurboSENSOR +™ Detachable 30K (Electric Blue ) |
| 00810000520985 | TurboSENSOR +™ Detachable 30K (Pearl) |
| 00810000520909 | TurboSENSOR +™ 30K Detachable Handpiece |