| Primary Device ID | 05056785302988 |
| NIH Device Record Key | 439a556f-7544-4025-b3c2-9b45afd77462 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kratz Plastic Mechanical Speculum |
| Version Model Number | 31-3005 |
| Company DUNS | 738288096 |
| Company Name | BLINK MEDICAL LIMITED |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056785302971 [Primary] |
| GS1 | 05056785302988 [Package] Contains: 05056785302971 Package: [10 Units] In Commercial Distribution |
| HNC | Specula, 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 | 2026-02-12 |
| Device Publish Date | 2026-02-04 |
| 05056785302988 - Kratz Plastic Mechanical Speculum | 2026-02-12 |
| 05056785302988 - Kratz Plastic Mechanical Speculum | 2026-02-12 |
| 05056785303008 - Plastic Solid Bladed Mechanical Speculum | 2026-02-12 |
| 05056785303367 - Double Ended Y and ICL Shaped Manipulator | 2026-02-12 |
| 05056785303343 - Connor Wand | 2026-02-03 |
| 05056785303268 - Cataract Instrument Pack - UCM | 2025-12-19 |
| 05056785302704 - Lenticule Removal Forceps, Serrated Jaw, Direct Action | 2025-11-24 |
| 05056785302728 - Lenticule Extraction Forceps, Serrated Jaw, Cross Action | 2025-11-24 |
| 05056785302742 - ICL Loading Forceps, Smooth Jaw, Direct Action | 2025-11-24 |