| Primary Device ID | 60889978580842 |
| NIH Device Record Key | db9bd342-9c4b-410e-9dd0-32296647fff9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LANEX Regular Screens |
| Version Model Number | LANEX Regular Screens |
| Catalog Number | 8580847 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, INC. |
| Device Count | 20 |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 24 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889978580840 [Unit of Use] |
| GS1 | 60889978580842 [Primary] |
| EAM | Screen, intensifying, radiographic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-16 |
| 60889978802098 | LANEX Regular SCR 20PR 4.88x14.75in H-G |
| 60889978580842 | LANEX Regular SCR 20PR 15x30cm H-Panoram |
| 60889971774644 | PR 24X30CM LANX SCR R C2 W/O FOAM |
| 60889971772565 | PR 35X43CM LANEX SCR REG C1 |
| 60889971772541 | PR 35X35CM LANEX SCR REG C1 |
| 60889971772480 | PR 24X30CM LANEX SCR REG C1 |
| 60889971772435 | PR 30X40CM LANX SCR R C2 W/O FOAM |
| 60889971772381 | PR 18X24CM LANEX SCR REG C1 |
| 60889971772336 | PR 18X24CM LANX SCR R C2 W/O FOAM |
| 60889971771438 | PR 35X43CM LANEX SCR REG C2 |
| 60889971771414 | PR 35X35CM LANEX SCR REG C2 |
| 60889971771339 | PR 24X30CM LANEX SCR REG C2 |
| 60889971771230 | PR 18X24CM LANEX SCR REG C2 |
| 60889971717740 | LANEX Regular SCR 20PR 8x10in NF |
| 60889971648563 | PR 30X120CM LANX SCR R C2 W/O FOAM |
| 60889971647207 | LANEX Regular SCR 1PR 15x30cm NF |
| 60889971414601 | LANEX Regular SCR 1PR 15x30cm hinged |
| 60889971414540 | LANEX Regular SCR 1PR 4.88x14.75in H |
| 60889971241436 | PR 30X35CM LANX SCR R C2 W/O FOAM |
| 60889971231390 | PR 14X17 LANX SCR R C2 W/O FOAM |
| 60889971231376 | PR 14X14 LANX SCR R C2 W/O FOAM |
| 60889971231352 | PR 11X14 LANX SCR R C2 W/O FOAM |
| 60889971231338 | PR 10X12 LANX SCR R C2 W/O FOAM |
| 60889971231291 | LANEX Regular SCR 1PR 8x10in NF |
| 60889971230850 | PR 14X36 LANX SCR R C2 W/O FOAM |
| 60889971207319 | PR 8X10 LANEX SCR REG C1 |
| 60889971976208 | LANEX Regular SCR 1PR 13x18cm |
| 60889971414687 | LANEX Regular SCR 1PR 5x12in NF |
| 60889971207371 | LANEX Regular SCR 1PR 8x10in |