| Primary Device ID | 60889971683373 |
| NIH Device Record Key | d8fab84b-aef2-44ae-8f7d-b4d379b6c951 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imaging Plate |
| Version Model Number | Imaging Plate |
| Catalog Number | 1683374 |
| Company DUNS | 793169512 |
| Company Name | CARESTREAM HEALTH, INC. |
| Device Count | 2 |
| 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 | true |
| 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 | 00889971683371 [Unit of Use] |
| GS1 | 40889971683379 [Primary] |
| GS1 | 60889971683373 [Package] Contains: 40889971683379 Package: Case [40 Units] In Commercial Distribution |
| 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 |
| 60889978770717 | CR IMAGING PLATE PAN V2 5X12IN |
| 60889978464913 | CR IMAGING PLATES CEPH 8X10IN |
| 60889978304899 | CR IMAGING PLATES PAN 5X12IN |
| 60889978025428 | CR IMAGING PLATES CEPH 18X24CM |
| 60889971251695 | 10SC 10X12 UB REPLACE PHSPHR CR SCN |
| 60889978610099 | (2) SZ 3 DENTAL CR I/O IMAG PLATES |
| 60889978406845 | (2) SZ 1 DENTAL CR I/O IMAG PLATES |
| 60889971683373 | (2) SZ 4 DENTAL CR I/O IMAG PLATES |
| 60889971435408 | CR SEMI-FIN PLATE CEPH 8X10IN |
| 60889971340078 | (2) SZ 2 DENTAL CR I/O IMAG PLATES |
| 60889971098917 | CR SEMI-FIN PLATE CEPH 18X24CM |
| 60889971067562 | Imaging Plate #2 - 4 Pcs |
| 60889971067555 | Imaging Plate #1 - 4 Pcs |
| 60889971067548 | Imaging Plate #0 - 4 Pcs |