| Primary Device ID | 00841668130803 |
| NIH Device Record Key | dcad359b-1acf-4200-a7a7-08c706d1692a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MANDEL KERATOMETER |
| Version Model Number | AE-2744 |
| Catalog Number | AE-2744 |
| Company DUNS | 085668598 |
| Company Name | KATENA PRODUCTS, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(973)989-1600 |
| inquiries.corzaeye@corza.com | |
| Phone | +1(973)989-1600 |
| inquiries.corzaeye@corza.com | |
| Phone | +1(973)989-1600 |
| inquiries.corzaeye@corza.com | |
| Phone | +1(973)989-1600 |
| inquiries.corzaeye@corza.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841668130803 [Primary] |
| HLF | Device, measuring, lens radius, ophthalmic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 00841668145906 - BLINK | 2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm), 4mm Tip |
| 00841668145913 - BLINK | 2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 4mm Tip |
| 00841668145920 - BLINK | 2026-03-31 Anterior Chamber Cannula - 21G21G x 7/8", (0.81 x 22mm), 4mm Tip |
| 00841668145937 - BLINK | 2026-03-31 Anterior Chamber Cannula - 27G27G x 7/8", (0.4 x 22mm), 6mm Tip |
| 00841668145944 - BLINK | 2026-03-31 Anterior Chamber Cannula - 30G30G x 7/8", (0.3 x 22mm) 6mm Tip |
| 00841668145951 - BLINK | 2026-03-31 Hydrodissector Cannula - 30G30G x 7/8", (0.3 x 22mm), Angled |
| 00841668145968 - BLINK | 2026-03-31 Irrigating Cystotome - 23G23G x 5/8", (0.64 x 16mm), Formed |
| 00841668145982 - BLINK | 2026-03-31 Irrigating Cystotome - 25G25G x 5/8", (0.5 x 16mm), Formed |