| Primary Device ID | 08033765391054 |
| NIH Device Record Key | e763ca39-8002-46fb-86c0-564d92e8243f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M8 |
| Version Model Number | F9000247 |
| Company DUNS | 429533573 |
| Company Name | ASA SRL |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033765391054 [Primary] |
| ILY | Lamp, Infrared, Therapeutic Heating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-04-18 |
| Device Publish Date | 2019-02-11 |
| 08033765391009 - ASA srl | 2025-04-18 |
| 08033765391016 - ASA srl | 2025-04-18 |
| 08033765391023 - ASA srl | 2025-04-18 |
| 08033765391054 - M8 | 2025-04-18 |
| 08033765391054 - M8 | 2025-04-18 |
| 08033765391207 - Mphi 7 | 2025-04-18 The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatmen |
| 08033765391757 - HIRO TT US | 2025-02-27 The HIRO TT US is an electrically-powered Nd:YAG laser intended to provide non-surgical infrared laser therapy for localized tre |
| 08033765391740 - M-Hi D US | 2024-10-18 The M-Hi D US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treat |
| 08033765391702 - M-Hi US | 2024-07-09 The M-Hi US is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatme |