| Primary Device ID | 10845819000981 |
| NIH Device Record Key | dd7cab09-1e6f-4b78-96c9-5942b87222cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Instruments |
| Version Model Number | 4017M, B-4017M |
| Company DUNS | 194121018 |
| Company Name | OASIS MEDICAL, 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 | false |
| 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 | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com | |
| Phone | 9093055400 |
| customerservice@oasismedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845819000984 [Primary] |
| GS1 | 10845819000981 [Package] Contains: 00845819000984 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 20845819000988 [Package] Contains: 00845819000984 Package: Plastic Bag [100 Units] In Commercial Distribution |
| HNY | Cystotome |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
[10845819000981]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-10 |
| Device Publish Date | 2023-06-30 |
| 20845819001596 | A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened, Bulk (Cardinal Healthcare), Bulk, Non-ste |
| 20845819001589 | Nucleus Hydrodissection Cannula, 27g x 7/8”, Sauter (Curved, Vertical Flow) (Cardinal Healthca |
| 20845819001558 | 25g LASIK Irrigator (Lindstrom), Bulk, Non-sterile |
| 20845819001534 | Hydrodissection Cannula (Chang), 27g x 3/4” (0.4mm x 19mm), 1mm Bend, Bulk, Non-sterile |
| 20845819001510 | Hydrodissection Cannula, 25g x 7/8”, (0.5 x 22mm), 8mm Bend, Bulk, Non-sterile |
| 20845819001497 | Irrigating Cystotome, Angled, 25g x 5/8” (0.5 x 16mm) Bulk, Non-sterile |
| 20845819001480 | Irrigating Cystotome, 25g x 5/8", Reverse Formed, Bulk, Non-Sterile |
| 20845819001473 | Irrigating Cystotome, Formed, 25g x 5/8”, (0.5 x 16mm) Bulk, Non-sterile |
| 20845819001466 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 6mm Bend, Bulk, Non-sterile |
| 20845819001459 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 4mm Bend, Bulk, Non-sterile |
| 20845819001442 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 8mm Bend (bulk, non-sterile) |
| 20845819001299 | Cortical Cleaving Hydrodissector, 27g x 7/8” (0.4 x 22mm), Flat End, 11mm Bend |
| 10845819006457 | Two-Port Subtenon Anesthesia Cannula 19g x 1”, Curved, Bulk, Non-Sterile |
| 10845819006440 | Anterior Chamber Cannula, 23g x 7/8” (0.64 x 22mm), 10mm Bend, Bulk, Non-Sterile |
| 10845819006365 | Hovis Hydrodissection Cannula, 27g x 7/8” (0.4 x 22mm), 4mm Bend |
| 10845819006358 | Cortex Extractor Cannula, Micro J-Shaped, 25g x 7/8” (0.5 x 22mm) |
| 10845819006334 | Olive Tip Capsule Polisher, 25g x 1”, Angled |
| 10845819006297 | Irrigating Cystotome, Angled, 27g x 5/8” (0.4 x 16mm) |
| 10845819006075 | Irrigating Cystotome, Formed, 27g x 5/8”, (0.4 x 16mm), Bulk, Non-sterile |
| 10845819006068 | Simcoe Cortex Extractor Cannula, 23g x 7/8” (0.64 x 22mm), Curved, Bulk, Non-sterile |
| 10845819006051 | Subtenon Cannula, 19g x1”, Flattened, Bulk, Non-sterile |
| 10845819006037 | Anterior Chamber Cannula, 30g x 7/8” (0.3 x 22mm), 4mm Bend, Bulk, Non-sterile |
| 10845819006013 | Anterior Chamber Cannula, 25g x 7/8” (0.5 x 22mm), 4mm Bend, Bulk, Non-sterile |
| 00845819005958 | Cortical Cleaving Hydrodissector 27g x 7/8” (0.4 x 22mm),11mm Bend, Round End, Bulk, Non-Steri |
| 10845819005337 | Irrigating Cystotome, Formed, 25g x 5/8”, 65° Angle, Bulk, Non-sterile |
| 10845819004910 | Terry Capsule Polisher, 27g x 7/8” (0.4 x 22mm), 6mm Bend |
| 10845819004897 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm) 9mm Bend, Non-Sterile |
| 10845819004873 | Capsulorhexis Cystotome, Formed, 27g x 5/8” (0.4 x 16mm), 90 degree Tip, Non-Sterile |
| 10845819002954 | Charleux Cannula, 23g x 1/2” (0.64 x 13mm), Curved, Non-Sterile |
| 10845819002947 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm) 9mm Bend, Non-Sterile |
| 10845819002930 | Anterior Chamber Cannula, 23g x 7/8” (0.64 x 22mm), 8mm Bend, Non-Sterile |
| 00845819001653 | Hovis Hydrodissection Cannula, 27g x 7/8”, 4mm Bend, in tray |
| 00845819001646 | Hydrodissection Cannula, 25g x 7/8” (0.5 x 22mm), 8mm Bend |
| 00845819001639 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 6mm Bend, bulk with tray. |
| 00845819001622 | LASIK Irrigator, 6 Side Ports |
| 00845819001608 | Alphachymotrypsin Cannula, 25g x 1-7/8” (0.5 x 48mm), Curved, (bulk, non-sterile) |
| 10845819001599 | A/C Washout Cannula, 19g x 1”, 8mm Bend, Flattened, Bulk (Cardinal Healthcare), Bulk, Non-ster |
| 10845819001582 | Nucleus Hydrodissection Cannula, 27g x 7/8”, Sauter (Curved, Vertical Flow) (Cardinal Healthca |
| 10845819001575 | Nucleus Hydrodissection Cannula, 25g x 7/8”, Sauter (Curved, Vertical Flow), Non-Sterile |
| 10845819001568 | 26g LASIK Irrigator – Slade, Bulk, Non-Sterile |
| 10845819001551 | 25g LASIK Irrigator (Lindstrom), Bulk, Non-sterile |
| 10845819001537 | Hydrodissection Cannula (Chang), 27g x 3/4” (0.4mm x 19mm), 1mm Bend, Bulk, Non-sterile |
| 10845819001520 | Hovis Hydrodissection Cannula, 25g x 7/8”, 4 mm Bend, Bulk, Non-sterile |
| 10845819001513 | Hydrodissection Cannula, 25g x 7/8”, (0.5 x 22mm), 8mm Bend, Bulk, Non-sterile |
| 10845819001506 | Kratz Capsule Polisher 21g x 7/8”, 9mm Bend, Bulk, Non-Sterile |
| 10845819001490 | Irrigating Cystotome, Angled, 25g x 5/8” (0.5 x 16mm) Bulk, Non-sterile |
| 10845819001483 | Irrigating Cystotome, 25g x 5/8", Reverse Formed, Bulk, Non-Sterile |
| 10845819001476 | Irrigating Cystotome, Formed, 25g x 5/8”, (0.5 x 16mm) Bulk, Non-sterile |
| 10845819001469 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 6mm Bend, Bulk, Non-sterile |
| 10845819001452 | Anterior Chamber Cannula, 27g x 7/8” (0.4 x 22mm), 4mm Bend, Bulk, Non-sterile |