3D-RD-S
GUDID 00860009926905
Dosimetry Software
Radiopharmaceutical Imaging and Dosimetry, LLC
Nuclear medicine system workstation| Primary Device ID | 00860009926905 |
| NIH Device Record Key | 6de08a79-a41e-42e5-8d9e-db5ae09f7e8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3D-RD-S |
| Version Model Number | 1.0.0 |
| Company DUNS | 080200015 |
| Company Name | Radiopharmaceutical Imaging and Dosimetry, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860009926905 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K212587
FDA Product Code
| IYX | Camera, Scintillation (Gamma) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-05 |
| Device Publish Date | 2023-03-28 |
Trademark Results [3D-RD-S]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 3D-RD-S 97893986 not registered Live/Pending |
Radiopharmaceutical Imaging and Dosimetry, LLC 2023-04-18 |
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