| Primary Device ID | 08175700116510 |
| NIH Device Record Key | 664e52e7-394c-4174-8ace-3c8643b6cc32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire Crescent Tunnel Knives |
| Version Model Number | AS6-021 |
| Catalog Number | AS6-021 |
| Company DUNS | 968368832 |
| Company Name | AURORA SURGICAL, 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com | |
| Phone | 7278213303 |
| info@aurorasurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08175700116510 [Primary] |
| HNN | Knife, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
[08175700116510]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
| 08175700116541 | Sapphire Crescent Tunnel 2.8mm wide, Angle Handle |
| 08175700116534 | Sapphire Crescent Tunnel 2.5mm wide, Angle Handle |
| 08175700116527 | Sapphire Crescent Tunnel 2.2mm wide, Angle Handle |
| 08175700116510 | Sapphire Crescent Tunnel 2.0mm wide, Angle Handle |
| 08175700116503 | Sapphire Crescent Tunnel 1.5mm wide, Angle Handle |