| Primary Device ID | 08051122041138 |
| NIH Device Record Key | 3c0fdf4e-3223-4972-bf1a-99fddae3d6f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elite Spk inserter |
| Version Model Number | P005_AS034_13 |
| Company DUNS | 429763668 |
| Company Name | NCS LAB 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08051122041138 [Primary] |
| LXH | Orthopedic Manual Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08051122041138]
Moist Heat or Steam Sterilization
[08051122041138]
Moist Heat or Steam Sterilization
[08051122041138]
Moist Heat or Steam Sterilization
[08051122041138]
Moist Heat or Steam Sterilization
[08051122041138]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-17 |
| Device Publish Date | 2022-06-09 |
| 08051122040902 - Shoulder Pacemaker device | 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c |
| 08051122040919 - Shoulder Pacemaker device (wireless PC) | 2022-11-29 The configuration is composed of an electrostimulator and other components, useful for recharging, wearing, stimulating and/or c |
| 08051122040926 - MySPM App | 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM mobile application, as accessory of the |
| 08051122040933 - MySPM@Home App | 2022-11-29 Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of |
| 08051122040940 - Stand-alone mode Kit | 2022-11-29 For the stand-alone mode version of the subject device, the SPM01K1 convenience kit includes: 1 electrostimulator SPM01M1 confi |
| 08051122040957 - Wireless mode - Kit | 2022-11-29 For the wireless mode version of the subject device, to be used in combination with a dedicated control software running on a pc |
| 08051122040964 - Wireless app mode - Kit | 2022-11-29 For the wireless mode version of the subject device, to be used in combination with an application installed on a tablet, the SP |
| 08051122040971 - Wireless app home mode - Kit | 2022-11-29 For the wireless mode version of the subject device, combined with an application installed on a tablet that can be used in a ho |