Fibreplast® with Integrated Shim™ RT-A892KSD
GUDID 10841962117996
Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962117996 |
| NIH Device Record Key | 54383b99-864e-4ffa-a545-b27173405cde |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® with Integrated Shim™ |
| Version Model Number | RT-A892KSD |
| Catalog Number | RT-A892KSD |
| Company DUNS | 808875397 |
| Company Name | Qfix |
| Device Count | 5 |
| 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 | 10841962117989 [Primary] |
| GS1 | 10841962117996 [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 | 2021-12-28 |
| Device Publish Date | 2021-12-20 |
On-Brand Devices [Fibreplast® with Integrated Shim™]
| 10841962117996 | Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim |
| 10841962117972 | Fibreplast Hd+Shldr Portrait S-Frame, 3.2mm Std Perf w/ Integrated Shim |
| 10841962117903 | Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std Perf w/ Integrated Shim |
| 10841962117880 | Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm Std 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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