Epredia AG00000112E01MNZ10
GUDID 00810041334015
NEW ERIE SCIENTIFIC LLC
General specimen microscopy slide IVD, single-use| Primary Device ID | 00810041334015 |
| NIH Device Record Key | 7a7939a8-8b0f-483f-9441-e412cdaf91ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epredia |
| Version Model Number | Microscope Slide Non Adhesion |
| Catalog Number | AG00000112E01MNZ10 |
| Company DUNS | 361605223 |
| Company Name | NEW ERIE SCIENTIFIC LLC |
| Device Count | 72 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810041334015 [Primary] |
| GS1 | 10810041334012 [Unit of Use] |
FDA Product Code
| KEW | Slides, Microscope |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-21 |
| Device Publish Date | 2025-02-13 |
On-Brand Devices [Epredia ]
Trademark Results [Epredia]
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 |
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