Encompass™ SRS Fibreplast® Anterior Mask RT-B889KYCF2A
GUDID 10841962118726
Encompass™ Fibreplast® Variable Perf Open View Anterior Only
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962118726 |
| NIH Device Record Key | 8bc1adfb-76a0-44e5-af8d-eb7b7ed2326c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Encompass™ SRS Fibreplast® Anterior Mask |
| Version Model Number | 10841962118726 |
| Catalog Number | RT-B889KYCF2A |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| Device Count | 1 |
| 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 | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com | |
| Phone | 610-268-0585 |
| Compliance@qfix.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841962118726 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152321
FDA Product Code
| LNH | System, Nuclear Magnetic Resonance Imaging |
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 | 2021-12-29 |
| Device Publish Date | 2021-12-21 |
Devices Manufactured by Qfix
| 00841962120340 - Edge Guide System | 2025-09-19 Lithotomy Edge Guide System |
| 00841962119467 - Alpine Stirrups | 2025-07-17 Stirrup, Left |
| 00841962119474 - Alpine Stirrups | 2025-07-17 Stirrup, Right |
| 00841962119481 - Symphony™ | 2025-07-17 Alta AirShuttle Upgrade |
| 00841962119498 - AirDrive Trolley™ | 2025-07-17 AirDrive Trolley IV Pole |
| 00841962119504 - Access Arm Support | 2025-07-17 Access Arm Support |
| 00841962119511 - Access Wrist Support | 2025-07-17 Access Wrist Support |
| 00841962119528 - AirShuttle Locating Bar | 2025-07-17 AirShuttle Locating Bar, Elekta Compatible |
Trademark Results [Encompass]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENCOMPASS 98779905 not registered Live/Pending |
Dymax Corporation 2024-10-01 |
 ENCOMPASS 98745682 not registered Live/Pending |
Yes Energy, LLC 2024-09-11 |
 ENCOMPASS 98697890 not registered Live/Pending |
Yes Energy, LLC 2024-08-14 |
 ENCOMPASS 98620248 not registered Live/Pending |
Encompass Onsite, LLC 2024-06-26 |
 ENCOMPASS 98573615 not registered Live/Pending |
Encompass Onsite, LLC 2024-05-29 |
 ENCOMPASS 98223659 not registered Live/Pending |
PT Intermediate Holdings IV, LLC 2023-10-13 |
 ENCOMPASS 98052738 not registered Live/Pending |
C. R. Bard, Inc. 2023-06-21 |
 ENCOMPASS 97826783 not registered Live/Pending |
Beauflor USA, LLC 2023-03-07 |
 ENCOMPASS 97825234 not registered Live/Pending |
QFIX SYSTEMS LLC 2023-03-06 |
 ENCOMPASS 97550970 not registered Live/Pending |
Mirvie, Inc. 2022-08-16 |
 ENCOMPASS 97353368 not registered Live/Pending |
Eyefinity, Inc. 2022-04-08 |
 ENCOMPASS 90975828 not registered Live/Pending |
The Scoular Company 2021-02-23 |
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