| Primary Device ID | 30850005541074 |
| NIH Device Record Key | 770433c2-5462-4050-a59a-3fd1f77e7682 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | miLOOP reusable |
| Version Model Number | FG-50896 |
| Company DUNS | 080125056 |
| Company Name | Carl Zeiss Meditec, Cataract Technology, Inc. |
| Device Count | 2 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850005541073 [Primary] |
| GS1 | 10850005541070 [Unit of Use] |
| GS1 | 30850005541074 [Package] Contains: 00850005541073 Package: Cardboard [4 Units] In Commercial Distribution |
| HNQ | Hook, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
[30850005541074]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-09-09 |
| Device Publish Date | 2024-08-30 |
| 00850005541080 - MICOR Auto I/A | 2025-08-27 MICOR Automatic Irrigation Device |
| 30850005541074 - miLOOP reusable | 2024-09-09Ophthalmic Instrument. Lens Fragmentation Device. |
| 30850005541074 - miLOOP reusable | 2024-09-09 Ophthalmic Instrument. Lens Fragmentation Device. |
| 00850005541042 - MICOR Vitrector | 2023-08-07 Ophthalmic Anterior Vitrectomy Device |