PolyPrep CD-PP-4000-S
GUDID 00840124514195
Push Pull
FUSION ORTHOPEDICS, LLC
Orthopaedic fixation plate file/rasp| Primary Device ID | 00840124514195 |
| NIH Device Record Key | 6dd95a70-c59e-475c-9957-a158dcff99fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PolyPrep |
| Version Model Number | CD-PP-4000-S |
| Catalog Number | CD-PP-4000-S |
| Company DUNS | 080307067 |
| Company Name | FUSION ORTHOPEDICS, LLC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840124514195 [Primary] |
FDA Product Code
| QBO | Instruments Designed For Press-Fit Osteochondral Implants |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-05 |
| Device Publish Date | 2024-10-28 |
Devices Manufactured by FUSION ORTHOPEDICS, LLC
| 00840124514225 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.3mm x 10mm |
| 00840124514232 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 12mm |
| 00840124514249 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 14mm |
| 00840124514256 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 16mm |
| 00840124514263 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 18mm |
| 00840124514270 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 20mm |
| 00840124514287 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 24mm |
| 00840124514294 - FuzeFix Chamfered Screws | 2024-11-19 Chamfered Screw 2.5mm x 22mm |
Trademark Results [PolyPrep]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POLYPREP 77911062 not registered Dead/Abandoned |
Plastic Dental Corporation 2010-01-13 |
 POLYPREP 75285762 2213912 Live/Registered |
HENKEL AG & CO. KGAA 1997-05-02 |
 POLYPREP 74275140 1783168 Dead/Cancelled |
Baker Hughes Incorporated 1992-05-13 |
 POLYPREP 73678897 1510960 Dead/Cancelled |
KENDALL COMPANY, THE 1987-08-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.