| Primary Device ID | 05060480409538 |
| NIH Device Record Key | 7fb61078-971b-435b-813b-1db9d32ca4b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Speculum Leibinger |
| Version Model Number | 31-3002 |
| 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 | 05056785300557 [Primary] |
| GS1 | 05060480409538 [Package] Contains: 05056785300557 Package: [100 Units] In Commercial Distribution |
| HNC | Specula, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
[05060480409538]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-26 |
| Device Publish Date | 2025-09-18 |
| 05060480407626 | 31-3002 |
| 05060480409538 | 31-3002 |