| Primary Device ID | 08806095799643 |
| NIH Device Record Key | 059e8d33-b375-47a9-ab1e-fc25c56b639f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | GF85-SP |
| Company DUNS | 687967554 |
| Company Name | Samsung Electronics Co., Ltd. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806095799643 [Primary] |
| KPR | System, X-Ray, Stationary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-28 |
| Device Publish Date | 2024-10-18 |
| 08806095799636 - NA | 2024-10-28 The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
| 08806095799643 - NA | 2024-10-28The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. |
| 08806095799643 - NA | 2024-10-28 The GF85 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trai |
| 08806094940756 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2024-07-15 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
| 08806094940763 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2024-07-15 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
| 08806094948233 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2023-10-31 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
| 08806094948240 - Samsung ECG Monitor App with Irregular Heart Rhythm Notification | 2023-10-31 The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile |
| 08806094744934 - NA | 2022-10-28 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |
| 08806094458213 - NA | 2022-05-12 Digital Flat Panel X-ray Detector used as part of Digital X-ray Imaging System that is intended for use in generating radiograph |