Fibreplast® Assure™ Open View RT-1778KFORF3
GUDID 10841962111734
Assure Open View Fibreplast 3-Point Mask
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962111734 |
| NIH Device Record Key | 235465bc-e0f7-40f2-8ef9-a6627ee4cd22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® Assure™ Open View |
| Version Model Number | RT-1778KFORF3 |
| Catalog Number | RT-1778KFORF3 |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| Device Count | 10 |
| DM Exempt | false |
| 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 | +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 | |
| 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 | |
| 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 | |
| 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 Dimensions
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
| Depth | 2.4 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841962111727 [Primary] |
| GS1 | 10841962111734 [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 | 2021-12-22 |
| Device Publish Date | 2021-12-14 |
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 |
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