Fibreplast® Variable Perf™ RT-1889KYESD
GUDID 10841962116081
Fibreplast Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962116081 |
| NIH Device Record Key | 471e5c6b-d126-465c-940c-7b0458faaf86 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® Variable Perf™ |
| Version Model Number | RT-1889KYESD |
| Catalog Number | RT-1889KYESD |
| 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 | |
| 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 | 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 | 10841962116074 [Primary] |
| GS1 | 10841962116081 [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 | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
On-Brand Devices [Fibreplast® Variable Perf™]
| 10841962117255 | Fibreplast VP HD+Shldr Portrait S-Frame, 3.2mm |
| 10841962117231 | Fibreplast VP HD+Shldr Portrait S-Frame, 3.2mm |
| 10841962117224 | Fibreplast Variable Perf, Head & Shoulder CURVE S-Frame, 3.2 mm |
| 10841962117200 | Fibreplast Variable Perf, Head & Shoulder CURVE S-Frame, 3.2 mm |
| 10841962116203 | Fibreplast VP Hd Only Portrait S-Frame, Std. 3.2mm |
| 10841962116180 | Fibreplast VP Hd Only Portrait S-Frame, Std. 3.2mm |
| 10841962116173 | Fibreplast VP, Slim U-Frame, Std. 3.2mm |
| 10841962116159 | Fibreplast VP, Slim U-Frame, Std. 3.2mm |
| 10841962116142 | Fibreplast 5-Point Mask, 3.2 mm, Variable Perf |
| 10841962116128 | Fibreplast 5-Point Mask, 3.2 mm, Variable Perf |
| 10841962116111 | Fibreplast 3-Point Mask, 3.2 mm, Variable Perf |
| 10841962116098 | Fibreplast 3-Point Mask, 3.2 mm, Variable Perf |
| 10841962116081 | Fibreplast Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard |
| 10841962116067 | Fibreplast Variable Perf, Head Only CURVE S-Frame, 3.2 mm, Standard |
| 10841962110126 | Fibreplast 5-Point Mask, 3.2 mm, Variable Perf |
| 10841962110119 | Fibreplast 3-Point Mask, 3.2 mm, Variable Perf |
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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