| Primary Device ID | 08800018420904 |
| NIH Device Record Key | 9c0c4ba2-c477-4261-81ef-dab92bb52073 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXTRON 7 |
| Version Model Number | EXTRON 7 |
| Company DUNS | 689842626 |
| Company Name | DRTECH Corporation |
| 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 | 08800018420904 [Primary] |
| OWB | Interventional Fluoroscopic X-Ray System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-01 |
| Device Publish Date | 2023-08-24 |
| 08800018421307 - LLD 129 Basic | 2023-11-13 The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone. |
| 08800018421406 - LLD 129 without rotation | 2023-11-13 The LLD Bucky Stand is combined with the General Xray system, is generally applicable to Xray radiography in Long bone. |
| 08800018407905 - EXPD 4357 | 2023-09-12 |
| 08800018408001 - EXPD 4357P | 2023-09-12 |
| 08800018421208 - DBS-57M | 2023-09-12 |
| 08800018420805 - EXTRON 5 | 2023-09-01 |
| 08800018420904 - EXTRON 7 | 2023-09-01 |
| 08800018420904 - EXTRON 7 | 2023-09-01 |
| 08800018423004 - AIDIA | 2023-06-23 The RMF-2000 generates 2D digital mammography images. The RMF-2000 is intended to be used for screening and diagnosis of breast |