Primary Device ID | 00840124514027 |
NIH Device Record Key | 19f6e1b6-bca7-4aa9-9025-7b5c62e7051f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FuzeFix Chamfered Screw |
Version Model Number | FX-CS-4052 |
Company DUNS | 080307067 |
Company Name | FUSION ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | true |
Pre-market Exempt | false |
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 | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00840124514027 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
[00840124514027]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-10-03 |
Device Publish Date | 2024-09-25 |
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 |