Fibreplast™ RT-1889KSXO
GUDID 10841962116036
Fibreplast Slim Org U-Frame, Ext , 3.2mm
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 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 | 10841962116036 |
| NIH Device Record Key | 5866b70e-e323-45b6-9a8b-75020b4ef2e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fibreplast™ |
| Version Model Number | RT-1889KSXO |
| Catalog Number | RT-1889KSXO |
| 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 | |
| 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 | 10841962116036 [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 | 2021-12-27 |
| Device Publish Date | 2021-12-17 |
On-Brand Devices [Fibreplast™]
| 10841962116036 | Fibreplast Slim Org U-Frame, Ext , 3.2mm |
| 10841962106235 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962106228 | Fibreplast PR 5-Point, 2.4mm Locks |
| 10841962106204 | Fibreplast PR 5-Point, 2.4mm |
| 10841962106198 | Fibreplast PR 5-Point, 2.4mm |
| 10841962106174 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962106167 | Fibreplast PR 3-Point, Std, 2.4mm Locks |
| 10841962106143 | Fibreplast PR 3-Point, Std, 2.4mm |
| 10841962106136 | Fibreplast PR 3-Point, Std, 2.4mm |
| 10841962106112 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962106105 | Fibreplast Orfit 5-Point, 2.4mm |
| 10841962106082 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962106075 | Fibreplast Orfit 3-Point, Std, 2.4mm |
| 10841962105276 | Fibreplast Splt Hd Only S-Frame, Ext. Face, 2.4mm |
| 10841962105269 | Fibreplast Splt Hd Only S-Frame, Ext. Face, 2.4mm |
| 10841962104552 | Fibreplast Slim U-Frame, Ext Face, 2.4mm |
| 10841962104545 | Fibreplast Slim U-Frame, Ext Face, 2.4mm |
| 10841962109694 | Fibreplast Hd Only CURVE S-Frame, Std, 2.4mm, 2.4mm 40%, Compatible w/CURVE Only |
| 10841962109687 | Fibreplast Hd Only CURVE S-Frame, Std, 2.4mm, 2.4mm 40%, Compatible w/CURVE Only |
| 10841962106891 | Fibreplast MT 3-Point Pelvis, 3.2mm |
| 10841962106884 | Fibreplast MT 3-Point Pelvis, 3.2mm |
| 10841962106266 | Fibreplast Reloadable Insert, Std, 2.4mm |
| 10841962106259 | Fibreplast Reloadable Insert, Std, 2.4mm |
| 10841962105511 | Fibreplast Hd Only Portrait S-Frame, Ext , 2.4mm |
| 10841962105504 | Fibreplast Hd Only Portrait S-Frame, Ext , 2.4mm |
| 10841962105481 | Fibreplast Splt Hd Only S-Frame Gap, 2.4mm |
| 10841962105474 | Fibreplast Splt Hd Only S-Frame Gap, 2.4mm |
| 10841962105450 | Fibreplast Hd Only Portrait S-Frame, Lng , 2.4mm |
| 10841962105443 | Fibreplast Hd Only Portrait S-Frame, Lng , 2.4mm |
| 10841962105429 | Fibreplast Hd Only Portrait S-Frame, Std, 2.4mm |
| 10841962105412 | Fibreplast Hd Only Portrait S-Frame, Std, 2.4mm |
| 10841962105399 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Long |
| 10841962105382 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Long |
| 10841962105368 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Standard |
| 10841962105351 | Fibreplast Head Only CURVE S-Frame, 2.4 mm, Standard |
| 10841962104705 | Fibreplast Splt Slim U-Frame Gap, Std, 2.4mm |
| 10841962104699 | Fibreplast Splt Slim U-Frame Gap, Std, 2.4mm |
| 10841962104675 | Fibreplast Slimline U-Frame, 2.4 mm, Extended |
| 10841962104668 | Fibreplast Slimline U-Frame, 2.4 mm, Extended |
| 10841962104644 | Fibreplast Slim U-Frame, Lng , 2.4mm |
| 10841962104637 | Fibreplast Slim U-Frame, Lng , 2.4mm |
| 10841962104613 | Fibreplast Slim U-Frame, Std, 2.4mm |
| 10841962104606 | Fibreplast Slim U-Frame, Std, 2.4mm |
| 10841962104460 | Fibreplast Sheet, 18" x 24". 3.2mm, Perf |
| 10841962104453 | Fibreplast Sheet, 18" x 24". 3.2mm, Perf |
| 10841962109793 | Fibreplast Sheet, 18" x 24", 3.2mm, Solid |
| 10841962109786 | Fibreplast Sheet, 18" x 24", 3.2mm, Solid |
| 10841962109731 | Fibreplast Sheet 18" x 24" 3.2mm 20% |
| 10841962109724 | Fibreplast Sheet 18" x 24" 3.2mm 20% |
| 10841962106860 | Fibreplast 43cm HD+Neck BoS Flap, 3.2mm |
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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