| Primary Device ID | 00810123481248 |
| NIH Device Record Key | 253902a9-87d4-45a4-b5ac-66aea7218a35 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Vortex Surgical Inc |
| Version Model Number | VS0744.25-35 |
| Company DUNS | 080375891 |
| Company Name | Vortex Surgical, Inc. |
| Device Count | 5 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810123481248 [Unit of Use] |
| GS1 | 00810123481651 [Primary] |
| HNR | Forceps, Ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-09 |
| Device Publish Date | 2023-02-01 |
| 00810123480142 | 27ga MAX Reach Laser Probe |
| 00810123480135 | 25ga Max Reach Laser Probe Box of 5 |
| 00810123480128 | 23ga MAX Reach Laser Probe |
| 00810123480111 | 25ga Flex-Tip Laser Probe |
| 00810123480104 | 23ga Flex-Tip Laser Probe |
| 00810123480050 | 27ga Curved Laser Probe |
| 00810123480043 | 25ga Curved Laser Probe |
| 00810123480036 | 23ga Curved Laser Probe |
| 00810123480029 | 27ga Straight Laser Probe |
| 00810123480012 | 25ga Straight Laser Probe |
| 00810123480005 | 23ga Straight Laser Probe |
| 00810123480395 | 25ga EZPass Soft Tip Cannula - 0.5mm Bulk Box of 100 |
| 00810123481903 | 25ga ACTU8 Myopic End Grip Forceps Box of 5 |
| 00810123481880 | 23ga ACTU8 Myopic End Grip Forceps Box of 5 |
| 00810123481866 | 27ga ACTU8 Myopic ILM Forceps Box of 5 |
| 00810123481323 | Beacon Illuminated Depressor Box of 5 |
| 00810123481309 | TID Pharos Illuminated Depressor - Bausch and Lomb Stellaris Box of 5 |
| 00810123481293 | TID Pharos Illuminated Depressor - Alcon Constellation Box of 5 |
| 00810123481286 | Todorich Illuminated Depressor (T.I.D.) Box of 5 |
| 00810123481279 | 25ga ACTU8 Asymmetrical Forceps Box of 5 |
| 00810123481262 | 23ga ACTU8 Asymmetrical Forceps Box of 5 |
| 00810123481255 | 27ga ACTU8 ILM Forceps Box of 5 |
| 00810123481248 | 25ga ACTU8 Myopic ILM Forceps Box of 5 |
| 00810123481231 | 25ga ACTU8 ILM Forceps Box of 5 |
| 00810123481224 | 23ga ACTU8 Myopic ILM Forceps Box of 5 |
| 00810123481217 | 23ga ACTU8 ILM Forceps Box of 5 |
| 00810123481200 | 25ga ACTU8 End Grip Forceps Box of 5 |
| 00810123481194 | 23ga ACTU8 End Grip Forceps Box of 5 |
| 00810123481187 | 25ga ACTU8 Myopic Tewari (T2) Forceps Box of 5 |
| 00810123481170 | 25ga ACTU8 Tewari (T2) Forceps Box of 5 |
| 00810123481163 | 23ga ACTU8 Myopic Tewari (T2) Forceps Box of 5 |
| 00810123481156 | 23ga ACTU8 Tewari (T2) Forceps Box of 5 |
| 00810123481149 | 27ga ACTU8 Adaptive Forceps Box of 5 |
| 00810123481132 | 25ga ACTU8 Adaptive Forceps Box of 5 |
| 00810123481125 | 23ga ACTU8 Adaptive Forceps Box of 5 |
| 00810123481118 | 27ga ACTU8 Pro-Grip Forceps Box of 5 |
| 00810123481101 | 25ga ACTU8 Pro-Grip Forceps Box of 5 |
| 00810123481095 | 23ga ACTU8 Pro-Grip Forceps Box of 5 |
| 00810123480449 | 30ga PC Maintainer Box of 10 |
| 00810123480432 | Curved Nano SubRet Gateway Device Box of 5 |
| 00810123480425 | Nano SubRet Gateway Device Box of 5 |
| 00810123480418 | 25ga Subretinal Injection Cannula Box of 5 |
| 00810123480401 | 27ga EZPass Soft Tip Cannula - 0.5mm Box of 5 |
| 00810123480388 | 23ga EZPass Soft Tip Cannula - 0.5mm Box of 5 |
| 00810123480371 | 27ga Dual Port Cannula Box of 5 |
| 00810123480364 | 27ga Side Port Cannula Box of 5 |
| 00810123480357 | 27ga Blunt Tip Cannula Box of 5 |
| 00810123480340 | 25ga Blunt Tip Cannula Box of 5 |
| 00810123480333 | 23ga Blunt Tip Cannula Box of 5 |
| 00810123480326 | 27ga EZPass Soft Tip Cannula Box of 5 |