Fibreplast® Assure™ Open View RT-1878KBOS-E2LF
GUDID 10841962114858
Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm
Qfix
Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material| Primary Device ID | 10841962114858 |
| NIH Device Record Key | 154c2b87-8165-46d9-b10a-400226039041 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® Assure™ Open View |
| Version Model Number | RT-1878KBOS-E2LF |
| Catalog Number | RT-1878KBOS-E2LF |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| Device Count | 10 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com |
Device Dimensions
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
| Depth | 3.2 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841962114841 [Primary] |
| GS1 | 10841962114858 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K935067
FDA Product Code
| IYE | Accelerator, Linear, Medical |
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 | 2021-12-24 |
| Device Publish Date | 2021-12-16 |
On-Brand Devices [Fibreplast® Assure™ Open View]
| 10841962111949 | Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks |
| 10841962111925 | Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks |
| 10841962111765 | Assure Open View Fibreplast 5 Point Mask |
| 10841962111741 | Assure Open View Fibreplast 5 Point Mask |
| 10841962111734 | Assure Open View Fibreplast 3-Point Mask |
| 10841962111710 | Assure Open View Fibreplast 3-Point Mask |
| 10841962111673 | Fibreplast Open Views HD Only Split U-Frame Ext |
| 10841962111659 | Fibreplast Open Views HD Only Split U-Frame Ext |
| 10841962111581 | Fibreplast Open View Slim Split-Frame U-Frame Ext |
| 10841962111567 | Fibreplast Open View Slim Split-Frame U-Frame Ext |
| 10841962113479 | Fibreplast Open View Hd + Shldr 2.4mm Micro Perf |
| 10841962113455 | Fibreplast Open View Hd + Shldr 2.4mm Micro Perf |
| 10841962114919 | Fibreplast Open View Hd + Shld 3.2mm Micro Perf |
| 10841962114896 | Fibreplast Open View Hd + Shld 3.2mm Micro Perf |
| 10841962114858 | Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm |
| 10841962114834 | Assure Open View Fibreplast 48 cm Hd+Shldr BoS Flap, 3.2 mm |
| 10841962114766 | Assure Open View Fibreplast 31 cm Hd+Neck BoS Flap, 3.2 mm |
| 10841962114742 | Assure Open View Fibreplast 31 cm Hd+Neck BoS Flap, 3.2 mm |
| 10841962114490 | Fibreplast Open View Split S-Frame 3.2mm |
| 10841962114476 | Fibreplast Open View Split S-Frame 3.2mm |
| 10841962114469 | Fibreplast Open View Slim Split Frame U-Frame Lng |
| 10841962114445 | Fibreplast Open View Slim Split Frame U-Frame Lng |
| 10841962114438 | Fibreplast Open View Spt Hd Only S-Frame |
| 10841962114414 | Fibreplast Open View Spt Hd Only S-Frame |
| 10841962114346 | Assure Open View Fibreplast 3 Point Mask |
| 10841962114322 | Assure Open View Fibreplast 3 Point Mask |
| 10841962116234 | Fibreplast Open View Slim Split-Frame U-Frame Lng. |
| 10841962116210 | Fibreplast Open View Slim Split-Frame U-Frame Lng. |
| 10841962117934 | Fibreplast Open View Spt Hd Only S-Frame, 3.2mm Micro Perf w/ Integrated Shim |
| 10841962117910 | Fibreplast Open View Spt Hd Only S-Frame, 3.2mm Micro Perf w/ Integrated Shim |
Trademark Results [Fibreplast]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FIBREPLAST 85862461 4414349 Live/Registered |
Qfix Systems LLC 2013-02-28 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.