| Primary Device ID | 07613353113049 |
| NIH Device Record Key | a22ea2c6-42d9-49ba-9df7-e676f5fd2b0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AIR-FLOW - PIEZON |
| Version Model Number | d |
| Catalog Number | EK-169 |
| Company DUNS | 481233849 |
| Company Name | E.M.S. Electro Medical Systems S.A. |
| 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 |
| Phone | +41229944700 |
| udi@ems-ch.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613353113049 [Primary] |
| EFB | Handpiece, Air-Powered, Dental |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-16 |
| 07613353334932 - AIR-FLOW | 2025-07-15 PERIOFLOW Handpiece set |
| 07613353342067 - AIR-FLOW | 2025-07-15 AirFlow MAX Handpiece |
| 07613353342074 - AIR-FLOW | 2025-07-15 PERIOFLOW HP WHITE |
| 07613353343965 - AIR-FLOW | 2025-07-15 AIRFLOW MAX Introduction Kit |
| 07613353337353 - PIEZON | 2025-06-18 Instrument A with combitorque |
| 07613353337360 - PIEZON | 2025-06-18 Instrument A x3 |
| 07613353337377 - PIEZON | 2025-06-18 Instrument P with combitorque |
| 07613353337438 - PIEZON | 2025-06-18 Complete PI instrument holder |