| Primary Device ID | 08809466040429 |
| NIH Device Record Key | db1f545a-04a3-4c40-91b4-a4c731c7d0e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cassette 35cmx43cm(IP 35cmx43cm)Kit |
| Version Model Number | CA04 |
| Company DUNS | 557815751 |
| Company Name | Digiray Corp. |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 0427103763 |
| kiwnd@digiray.co.kr |
| Weight | 1.9 Kilogram |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809466040429 [Primary] |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-07 |
| Device Publish Date | 2016-08-02 |
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