Fibreplast® RT-1889KESDX
GUDID 10841962115756
Fibreplast Hd Only CURVE S-Frame, Ext, 3.2mm
Qfix
Patient positioning thermoplastic mould material| Primary Device ID | 10841962115756 |
| NIH Device Record Key | f8bbc28c-02ff-41fe-adfa-2668bd1f8f36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast® |
| Version Model Number | RT-1889KESDX |
| Catalog Number | RT-1889KESDX |
| 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 | 10841962115749 [Primary] |
| GS1 | 10841962115756 [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®]
| 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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