| Primary Device ID | 06977501300264 |
| NIH Device Record Key | 726e93d8-5978-4567-8630-efc333f5dce8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Medical CT X-Ray Tube Assembly |
| Version Model Number | CTA300L2 |
| Company DUNS | 976891566 |
| Company Name | Wuxi Guochen Medical Technology Co., Ltd. |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06977501300264 [Primary] |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-08 |
| 06977501300271 | Medical CT X-Ray Tube Assembly |
| 06977501300264 | Medical CT X-Ray Tube Assembly |
| 06977501300257 | Medical CT X-Ray Tube Assembly |
| 06977501300240 | Medical CT X-Ray Tube Assembly |
| 06977501300233 | Medical CT X-Ray Tube Assembly |
| 06977501300226 | Medical CT X-Ray Tube Assembly |
| 06977501300219 | Medical CT X-Ray Tube Assembly |
| 06977501300202 | Medical CT X-Ray Tube Assembly |
| 06977501300196 | Medical CT X-Ray Tube Assembly |
| 06977501300189 | Medical CT X-Ray Tube Assembly |
| 06977501300172 | Medical CT X-Ray Tube Assembly |
| 06977501300165 | Medical CT X-Ray Tube Assembly |
| 06977501300158 | Medical CT X-Ray Tube Assembly |
| 06977501300141 | Medical CT X-Ray Tube Assembly |
| 06977501300134 | Medical CT X-Ray Tube Assembly |
| 06977501300127 | Medical CT X-Ray Tube Assembly |
| 06977501300110 | Medical CT X-Ray Tube Assembly |
| 06977501300103 | Medical CT X-Ray Tube Assembly |
| 06977501300097 | Medical CT X-Ray Tube Assembly |
| 06977501300080 | Medical CT X-Ray Tube Assembly |
| 06977501300066 | Medical CT X-Ray Tube Assembly |
| 06977501300059 | Medical CT X-Ray Tube Assembly |
| 06977501300042 | Medical CT X-Ray Tube Assembly |
| 06977501300035 | Medical CT X-Ray Tube Assembly |