Fibreplast® Micro Perf™ Assure™ Open View RT-1778KSDF
GUDID 10841962111970
Fibreplast Open View Hd +Shldr 2.4mm Micro Perf
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962111970 |
| NIH Device Record Key | 76598c7c-bd79-4e8d-8cfb-ae4bbfd03c9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® Micro Perf™ Assure™ Open View |
| Version Model Number | RT-1778KSDF |
| Catalog Number | RT-1778KSDF |
| 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 | 10841962111963 [Primary] |
| GS1 | 10841962111970 [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® Micro Perf™ Assure™ Open View]
| 10841962111970 | Fibreplast Open View Hd +Shldr 2.4mm Micro Perf |
| 10841962111956 | Fibreplast Open View Hd +Shldr 2.4mm Micro Perf |
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.