| Primary Device ID | 10810090013975 |
| NIH Device Record Key | bff420bf-b8d0-481b-8bc8-408a15b9e23c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | 620-10 |
| Company DUNS | 555862549 |
| Company Name | Eagle Labs |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 909-481-0011 |
| eaglelabs@eaglelabs.com | |
| Phone | 909-481-0011 |
| eaglelabs@eaglelabs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810090013978 [Primary] |
| GS1 | 10810090013975 [Package] Contains: 00810090013978 Package: carton [20 Units] In Commercial Distribution |
| HOZ | Sponge, Ophthalmic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10810090013975]
Radiation Sterilization
[10810090013975]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-10-28 |
| 00810090014203 | PVA Eye Spears, 5 ea |
| 10810090014163 | LASIK Shield, 7mm diameter, 5mm edge |
| 10810090014149 | Non-woven half body drape with adhesive aperture and fluid collection pouch |
| 10810090013975 | LASIK Shield, Dual Edge, 4mm and 8mm |
| 10810090013968 | LASIK shield, 8mm diameter, 6mm edge |
| 10810090013920 | LASIK sponge, 11mm opening |
| 10810090013913 | LASIK Drainage Ring, Superior Hinge, 9.5mm opening |
| 00810090013909 | Eye Pledget, Lint free PVS eye sponges, 2mm x 6mm - 10 in one package |
| 10810090013517 | PVA Pre-expanded Eye Spears, 2 ea |
| 10810090013494 | Non-woven Half Body drape with adhesive incise and fluid collection pouch |
| 10810090013395 | LASIK Shield, 9mm diameter, 7mm edge |
| 10810090013388 | LASIK Drainage Ring (Chayet), 12mm opening |
| 10810090013302 | PVA Eye Spears - 5 ea |
| 00810090013299 | One package of 10 cellulose eye sponges |
| 10810090012602 | Refractive Drape, 16" x 10.7" (41cm x 27cm), with split aperture |
| 10810090011612 | Medium plastic drape, 50" x 32" (127cm x 81cm), with adhesive aperture |
| 10810090011476 | Medium plastic drape, 48" x 51" (122cm x 130cm), with adhesive incise and fluid collection |
| 10810090011445 | Medium plastic drape, 48" x 50" (122cm x 127cm), with adhesive incise |
| 10810090011438 | Small plastic drape, 16" x 16" (41cm x 41cm), with adhesive incise |
| 10810090011292 | Small plastic drape, 16"x16" (41cm x 41cm), with adhesive aperture |