| Primary Device ID | 08175700149006 |
| NIH Device Record Key | ad9857ec-2301-47fe-897b-2aad9cb4b775 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anesthesia / Cytotomes |
| Version Model Number | AS13-1000-23g |
| Catalog Number | AS13-1000-23g |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08175700149006 [Primary] |
| HMX | Cannula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
[08175700149006]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-18 |
| Device Publish Date | 2023-07-10 |
| 08175700149082 | Peribulbar Needle (Atkinson) 27g x 22mm |
| 08175700149075 | Peribulbar Needle (Atkinson) 25g x 22mm |
| 08175700149068 | Peribulbar Needle (Atkinson) 23g x 22mm |
| 08175700149051 | Retrobulbar Needle (Sharp Point) 27g x 50mm |
| 08175700149044 | Retrobulbar Needle (Sharp Point) 25g x 38mm |
| 08175700149037 | Retrobulbar Needle (Sharp Point) 23g x 38mm |
| 08175700149020 | Retrobulbar Needle (Atkinson) 27g x 38mm |
| 08175700149013 | Retrobulbar Needle (Atkinson) 25g x 38mm |
| 08175700149006 | Retrobulbar Needle (Atkinson) 23g x 38mm |
| 08175700149112 | Cystotome Formed 27ga with Small Cystotome Sharp Cutting Edge, Angled/Vaulted 12mm from bend to |
| 08175700149105 | Cystotome Formed 25ga with Small Cystotome Sharp Cutting Edge, Angled/Vaulted 12mm from bend to |