| Primary Device ID | J021304670000 |
| NIH Device Record Key | 5efab99a-d2aa-41f1-98ec-868f9325a591 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | S-9 ES RIWOSpine |
| Version Model Number | 30467000 |
| Company DUNS | 300238441 |
| Company Name | W & H Dentalwerk Bürmoos GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J021304670000 [Direct Marking] |
| HIBCC | J021304670001 [Primary] |
| GEY | Motor, Surgical Instrument, Ac-Powered |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
[J021304670000]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-15 |
| Device Publish Date | 2024-02-07 |
| J021305030001 - Piezomed Pro Accessory | 2025-09-30 Instrument MP1-S |
| J021305030011 - Piezomed Pro Accessory | 2025-09-30 Instrument MR1-S |
| J021305030021 - Piezomed Pro Accessory | 2025-09-30 Instrument MR2-S |
| J021305030031 - Piezomed Pro Accessory | 2025-09-30 Instrument MR3-S |
| J021305030041 - Piezomed Pro Accessory | 2025-09-30 Instrument MR4-S |
| J021305030051 - Piezomed Pro Accessory | 2025-09-30 Instrument MR5-S |
| J021305030061 - Piezomed Pro Accessory | 2025-09-30 Instrument MR6-S |
| J021305030071 - Piezomed Pro Accessory | 2025-09-30 Instrument MS1-S |