| Primary Device ID | 10841962110478 |
| NIH Device Record Key | 1d1566a4-7d91-4c9b-b5a3-c046e86849e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pediatric Table, OPERON D 750-D 850 (EU) |
| Version Model Number | 8000105 |
| Catalog Number | 8000105 |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Width | 12.25 Inch |
| Width | 1 Inch |
| Device Size Text, specify | 0 |
| Width | 21 Inch |
| Length | 36 Inch |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841962110478 [Primary] |
| GDC | TABLE, OPERATING-ROOM, ELECTRICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-12-11 |
| Device Publish Date | 2017-05-30 |
| 00841962120388 - Lumen AirShuttle | 2025-12-10 Lumen AirShuttle |
| 00841962120395 - Symphony Locating Bar, PH Style | 2025-12-10 Symphony Locating Bar, PH Style |
| 00841962120401 - Portrait Head Only Mask Adapter for Access Supine | 2025-12-10 Portrait Head Only Mask Adapter for Access Supine |
| 00841962120418 - Portrait Head & Neck Mask Adapter for Access Supine | 2025-12-10 Portrait Head & Neck Mask Adapter for Access Supine |
| 10841962119464 - Symphony Locating Bar, PH Style | 2025-12-03 Symphony Locating Bar, PH Style |
| 00841962119856 - IntegraBite | 2025-11-21 IntegraBite Plates |
| 00841962120340 - Edge Guide System | 2025-09-19 Lithotomy Edge Guide System |
| 00841962119467 - Alpine Stirrups | 2025-07-17 Stirrup, Left |