| Primary Device ID | 00810041333643 |
| NIH Device Record Key | b690a984-d17f-4672-ab29-a838f777e36a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epredia |
| Version Model Number | Cover Slips |
| Catalog Number | BC02500750A140MNZ0 |
| Company DUNS | 361605223 |
| Company Name | NEW ERIE SCIENTIFIC LLC |
| Device Count | 1000 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810041333643 [Primary] |
| GS1 | 10810041333640 [Unit of Use] |
| KES | Coverslips, Microscope Slide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-21 |
| Device Publish Date | 2025-02-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPREDIA 97821165 not registered Live/Pending |
New Erie Scientific LLC 2023-03-03 |
![]() EPREDIA 88473846 not registered Live/Pending |
New Erie Scientific LLC 2019-06-14 |