Primary Device ID | 00819034021796 |
NIH Device Record Key | 165ec36f-7785-41c8-b32b-eeb7d67edf8b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FuzeFix™ Twist Off |
Version Model Number | FX-TW-2516 |
Catalog Number | FX-TW-2516 |
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 | false |
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 | 00819034021796 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00819034021796]
Moist Heat or Steam Sterilization
[00819034021796]
Moist Heat or Steam Sterilization
[00819034021796]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-11-07 |
00819034021826 | TW 2.5mm x 22mm |
00819034021819 | TW 2.5mm x 20mm |
00819034021802 | TW 2.5mm x 18mm |
00819034021796 | TW 2.5mm x 16mm |
00819034021789 | TW 2.5mm x 15mm |
00819034021772 | TW 2.5mm x 14mm |
00819034021765 | TW 2.5mm x 13mm |
00819034021758 | TW 2.5mm x 12mm |
00819034021741 | TW 2.5mm x 11mm |
00819034021734 | TW 2.5mm x 10mm |
00819034021727 | TW 2.0mm x 22mm |
00819034021710 | TW 2.0mm x 20mm |
00819034021703 | TW 2.0mm x 18mm |
00819034021697 | TW 2.0mm x 16mm |
00819034021680 | TW 2.0mm x 15mm |
00819034021673 | TW 2.0mm x 14mm |
00819034021666 | TW 2.0mm x 13mm |
00819034021659 | TW 2.0mm x 12mm |
00819034021642 | TW 2.0mm x 11mm |
00819034021635 | TW 2.0mm x 10mm |