| Primary Device ID | 08904269400590 |
| NIH Device Record Key | 7d7f31e6-7e50-48f0-aa9f-cab3db942c5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imagescan HD |
| Version Model Number | 303-001204-0 |
| Company DUNS | 863358955 |
| Company Name | SKANRAY TECHNOLOGIES PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08904269400590 [Primary] |
| EHD | Unit, X-Ray, Extraoral With Timer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-18 |
| Device Publish Date | 2020-08-10 |
| 08904269400590 | Imagescan HD Floor stand is High Frequency Extra oral X-Ray source to be used for Intra oral X-R |
| 08904269400583 | Imagescan HD with 33" Straight arm is High Frequency Extra oral X-Ray source to be used for Intr |
| 08904269400576 | Imagescan HD with 24" Straight arm is High Frequency Extra oral X-Ray source to be used for Intr |
| 08904269400569 | Imagescan HD with 15" Straight arm is High Frequency Extra oral X-Ray source to be used for Intr |