| Primary Device ID | 60889971435408 | 
| NIH Device Record Key | ca8d7183-5c81-40d4-be32-3ad2526e0363 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Imaging Plate | 
| Version Model Number | Imaging Plate | 
| Catalog Number | 1435403 | 
| Company DUNS | 793169512 | 
| Company Name | CARESTREAM HEALTH, INC. | 
| 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 | 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 | 40889971435404 [Primary] | 
| GS1 | 60889971435408 [Package] Contains: 40889971435404 Package: Case [20 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 |