| Primary Device ID | 04711552929782 |
| NIH Device Record Key | b4362ea2-8482-451b-8b6b-4965f1a6ecbf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cenefom |
| Version Model Number | OP-IW01 |
| Company DUNS | 658868262 |
| Company Name | CENEFOM CORP. |
| Device Count | 20 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| 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 | 04711552929768 [Unit of Use] |
| GS1 | 04711552929775 [Primary] |
| GS1 | 04711552929782 [Package] Contains: 04711552929775 Package: Carton [50 Units] In Commercial Distribution |
| HOZ | Sponge, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[04711552929782]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-31 |
| 04711552929782 | Wipe |
| 04711552929751 | LASIK eye drain 12mm |
| 04711552929683 | LASIK Ring 12mm |
| 04711552920352 | Corneal light shield |
| 04711552920321 | Epistaxis Type Nasal Packing |