Fibreplast® RT-1779KSDX
GUDID 10841962112618
Fibreplast Hd Only Portrait S-Frame, Ext , 2.4mm
Qfix
Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material| Primary Device ID | 10841962112618 |
| NIH Device Record Key | 2e8e7b0c-74b5-40ca-902e-cd66887bd6fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® |
| Version Model Number | RT-1779KSDX |
| Catalog Number | RT-1779KSDX |
| 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 | +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 | 10841962112618 [Primary] |
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 | 2021-12-23 |
| Device Publish Date | 2021-12-15 |
On-Brand Devices [Fibreplast®]
| 10841962111178 | Fibreplast Head Only BoS, 3.2mm Standard Perf |
| 10841962111147 | Fibreplast Head Only BoS, 3.2mm Standard Perf |
| 10841962111918 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962111895 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962111857 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962111833 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962111826 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962111802 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962111796 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962111772 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962111611 | Fibreplast Slim U-Frame, Ext Face, 2.4mm |
| 10841962111598 | Fibreplast Slim U-Frame, Ext Face, 2.4mm |
| 10841962111550 | Fibreplast Splt Hd Only S-Frame, Ext. Face, 2.4mm |
| 10841962111536 | Fibreplast Splt Hd Only S-Frame, Ext. Face, 2.4mm |
| 10841962113448 | Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm |
| 10841962113424 | Fibreplast Hd+Shldr Portrait S-Frame, 2.4mm |
| 10841962113417 | Fibreplast Reloadable Hd+Shldr S-Frame, 2.4mm |
| 10841962113394 | Fibreplast Reloadable Hd+Shldr S-Frame, 2.4mm |
| 10841962113387 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962113363 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962113356 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962113332 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962113325 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962113301 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962113295 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962113271 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962113264 | Fibreplast Head & Shoulder CURVE S-Frame, 2.4 mm |
| 10841962113240 | Fibreplast Head & Shoulder CURVE S-Frame, 2.4 mm |
| 10841962112694 | Fibreplast Slimline U-Frame, 2.4 mm, Extended |
| 10841962112670 | Fibreplast Slimline U-Frame, 2.4 mm, Extended |
| 10841962112663 | Fibreplast Slim U-Frame, Lng , 2.4mm |
| 10841962112649 | Fibreplast Slim U-Frame, Lng , 2.4mm |
| 10841962112632 | Fibreplast Hd Only Portrait S-Frame, Ext , 2.4mm |
| 10841962112618 | Fibreplast Hd Only Portrait S-Frame, Ext , 2.4mm |
| 10841962112601 | Fibreplast Splt Hd Only S-Frame Gap, 2.4mm |
| 10841962112588 | Fibreplast Splt Hd Only S-Frame Gap, 2.4mm |
| 10841962112571 | Fibreplast Hd Only Portrait S-Frame, Lng , 2.4mm |
| 10841962112557 | Fibreplast Hd Only Portrait S-Frame, Lng , 2.4mm |
| 10841962112540 | Fibreplast Hd Only Portrait S-Frame, Std, 2.4mm |
| 10841962112526 | Fibreplast Hd Only Portrait S-Frame, Std, 2.4mm |
| 10841962112519 | Fibreplast Slim U-Frame, Std, 2.4mm |
| 10841962112496 | Fibreplast Slim U-Frame, Std, 2.4mm |
| 10841962112489 | Fibreplast Reloadable Insert, Std, 2.4mm |
| 10841962112465 | Fibreplast Reloadable Insert, Std, 2.4mm |
| 10841962112458 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Standard |
| 10841962112434 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Standard |
| 10841962112427 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Long |
| 10841962112403 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Long |
| 10841962112397 | Fibreplast Hd Only CURVE S-Frame, Std, 2.4mm, 2.4mm 40%, Compatible w/CURVE Only |
| 10841962112373 | Fibreplast Hd Only CURVE S-Frame, Std, 2.4mm, 2.4mm 40%, Compatible w/CURVE Only |
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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