| Primary Device ID | 00817489026267 |
| NIH Device Record Key | 14abda6b-66b8-46cf-af71-52aeb566e5ae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disposable Iris Retractor Hooks |
| Version Model Number | D4176-5 |
| Company DUNS | 007883297 |
| Company Name | KATALYST 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817489026267 [Primary] |
| GS1 | 10817489026264 [Package] Package: Pack of Hooks [5 Units] In Commercial Distribution |
| GS1 | 20817489026261 [Package] Package: Pack of Hooks [2 Units] In Commercial Distribution |
| HNI | Retractor, 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 | 2025-05-06 |
| Device Publish Date | 2025-04-28 |
| 00840096207606 - DEX TIPS™ Universal Handle | 2026-01-12 DEX TIPS™ Universal Handle |
| 00840096207613 - DEX TIPS™ Universal Slim Handle | 2026-01-12 DEX TIPS™ Universal Slim Handle |
| 10817489025298 - Cyclophotocoagulation Probe, Quantel Connector | 2026-01-05 |
| 10817489025304 - Cyclophotocoagulation Probe, Iridex Connector | 2026-01-05 |
| 10817489024536 - Revolver Fiber | 2025-07-03 |
| 10817489024833 - Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5 | 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 0.5mm Straight Tips, Box of 5 |
| 10817489024840 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5 | 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.0mm Straight Tips, Box of 5 |
| 10817489024857 - Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5 | 2025-07-03 Disposable Bipolar Focused Irrigating Forceps, 7", 1.5mm Straight Tips, Box of 5 |