| Primary Device ID | 10840113232847 |
| NIH Device Record Key | e937eae3-81a1-473d-9a1d-c7d55523cae3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skytron Lumos |
| Version Model Number | B1-530-18 |
| Company DUNS | 027680821 |
| Company Name | ASPEN SURGICAL PRODUCTS, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com | |
| Phone | +1(616)698-7100 |
| customerservice@aspensurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840113232840 [Primary] |
| GS1 | 10840113232847 [Package] Contains: 00840113232840 Package: [20 Units] In Commercial Distribution |
| FTA | Light, surgical, accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-14 |
| Device Publish Date | 2024-06-06 |
| 10840113232847 | Disposable camera cover for Lumos series lights |
| 10840113232830 | Disposable rigid handle for Lumos series lights |