| Primary Device ID | 06430035872794 |
| NIH Device Record Key | 4cb00c2d-b485-4410-9e7a-5ddae74fe54a |
| Commercial Distribution Discontinuation | 2019-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | FS Ergo |
| Version Model Number | KFS-1-M |
| Catalog Number | 901039 |
| Company DUNS | 459955188 |
| Company Name | PaloDEx Group Oy |
| 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 | 06430035872794 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-01-27 |
| Device Publish Date | 2018-01-19 |
| 06430035875139 - ORTHOPANTOMOGRAPH™ OP 3D | 2024-03-22 OP 3D LX CEPH UPGRADE KIT |
| 06430035875092 - ORTHOPANTOMOGRAPH™ OP 3D | 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D) |
| 06430035875108 - ORTHOPANTOMOGRAPH™ OP 3D | 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN, CEPH 3D) |
| 06430035873630 - Orthopantomograph OP 3D | 2021-06-08 |
| 06430035874484 - OP 3D Carpus Holder | 2021-06-04 Carpus holder for Carpus imaging with Orthopantomograph OP 3D |
| 06430035874354 - Bite blocks 10pcs OP 3D | 2021-06-03 |
| 06430035874422 - CRANEX 3D PAT POSIT ACCESSORIES | 2021-06-03 |
| 06430035874439 - CRANEX 3D PAN ACCESSORIES | 2021-06-03 |