Fibreplast® Assure™ Open View RT-1778KPR3DF
GUDID 10841962111888
Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962111888 |
| NIH Device Record Key | 8f9bc6e0-c662-4048-a7f7-04e892f0dfde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® Assure™ Open View |
| Version Model Number | RT-1778KPR3DF |
| Catalog Number | RT-1778KPR3DF |
| 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 | 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 | 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 | 10841962111871 [Primary] |
| GS1 | 10841962111888 [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]
| 10841962111888 | Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks |
| 10841962111864 | Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks |
| 10841962114377 | Assure Open View Fibreplast 5 Point Mask |
| 10841962114353 | Assure Open View Fibreplast 5 Point Mask |
| 10841962110584 | Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks |
| 10841962110577 | Assure Open View Fibreplast PR 5-Point, 2.4 mm Locks |
| 10841962110553 | Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks |
| 10841962110546 | Assure Open View Fibreplast PR 3-Point, 2.4 mm Locks |
| 10841962110140 | Assure Open View Fibreplast 5 Point Mask |
| 10841962110133 | Assure Open View Fibreplast 3-Point Mask |
| 10841962110249 | Assure Open View Fibreplast 5 Point Mask |
| 10841962110232 | Assure Open View Fibreplast 3 Point Mask |
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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