| Primary Device ID | 10841736123185 |
| NIH Device Record Key | 2eaf7a28-16e3-4b72-8198-bd3d7a3281fb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Center Focus Handle |
| Version Model Number | B1-530-40 |
| Company DUNS | 078375583 |
| Company Name | SKYTRON LLC |
| 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 | 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 | true |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us | |
| Phone | 1-800-759-8766 |
| info@skytron.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841736123185 [Primary] |
| FTA | Light, Surgical, Accessories |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
[10841736123185]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-23 |
| Device Publish Date | 2022-02-15 |
| 20841736110564 | Center Focus Handle with Intensity Control for Aurora II, Aurora 3, and Aurora Four Lights. |
| 20841736100275 | Center Focus Handle with Intensity Control for Aurora II, Aurora 3 and Aurora Four Lights |
| 10841736123185 | Center Focus Handle with Intensity Control for Lumos Series |
| 10841736124151 | Center Focus Handle with Intensity Control for Lumos Series, black |