BIOSCREW C8016
GUDID 00845854034081
BIOSCREW GUIDE WIRES, 356MM (14 IN)
Conmed Corporation
Orthopaedic implantation sleeve, reusable| Primary Device ID | 00845854034081 |
| NIH Device Record Key | 95adc7b4-e468-4536-89d4-a1d0bd3a1776 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIOSCREW |
| Version Model Number | C8016 |
| Catalog Number | C8016 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 5 |
| DM Exempt | false |
| 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 | false |
| 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
Device Dimensions
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
| Length | 256 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845854034081 [Unit of Use] |
| GS1 | 10845854034088 [Primary] |
| GS1 | 20845854034085 [Direct Marking] |
| GS1 | 30845854034082 [Previous] |
FDA Product Code
| LXH | Orthopedic manual surgical instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
[00845854034081]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-13 |
| Device Publish Date | 2023-12-05 |
On-Brand Devices [BIOSCREW]
| 20845854014476 | BIOSCREW 8MM X 20MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854014452 | BIOSCREW 9MM X 30MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014445 | BIOSCREW 7MM X 25MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014407 | BIOSCREW 8MM X 25MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854014391 | BIOSCREW 8MM X 25MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014360 | BIOSCREW 7MM X 25MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854014346 | BIOSCREW 11MM X 25MM, BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014339 | BIOSCREW 9MM X 20MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014131 | BIOSCREW 9MM X 25MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014049 | BIOSCREW 7MM X 30MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854014001 | BIOSCREW 7MM X 20MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013752 | BIOSCREW 8MM X 30MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854013745 | BIOSCREW 7MM X 30MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854013738 | BIOSCREW 9MM X 30MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854013721 | BIOSCREW 9MM X 20MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854013684 | BIOSCREW 8MM X 20MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013622 | BIOSCREW 10MM X 30MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013615 | BIOSCREW 11MM X 30MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013608 | BIOSCREW 10MM X 25MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013592 | BIOSCREW 8MM X 30MM BIOABSORBABLE INTERFERENCE SCREW |
| 20845854013561 | BIOSCREW 7MM X 20MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854013479 | BIOSCREW 9MM X 25MM BIOABSORBABLE FEMORAL INTERFERENCE SCREW |
| 20845854016678 | BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.), QTY 5 |
| 20845854034337 | BIOSCREW UNIVERSAL TRI-LOBE MODULAR DRIVER |
| 20845854026769 | BIOSCREW FLEXIBLE DRIVER |
| 20845854016661 | BIOSCREW UNIVERSAL TRI-LOBE DRIVER |
| 20845854034085 | BIOSCREW GUIDE WIRES, 356MM (14 IN), QTY 5 |
| 20845854041700 | BioScrew Guidewire, SST, 14in, Sterile |
| 30845854013605 | BIOSCREW 10MM X 25MM BIOABSORBABLE INTERFERENCE SCREW |
| 00845854034081 | BIOSCREW GUIDE WIRES, 356MM (14 IN) |
| 00845854016674 | BIOSCREW HYPERFLEX GUIDEWIRES, 356MM (14 IN.) |
Trademark Results [BIOSCREW]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOSCREW 86673937 4954423 Live/Registered |
Conmed Corporation 2015-06-25 |
 BIOSCREW 74105000 1724608 Dead/Cancelled |
LINVATEC CORPORATION 1990-10-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.