Primary Device ID | 00852164007278 |
NIH Device Record Key | e3a5a70a-8ecb-45e1-8026-ca3b1778aa91 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HammerTech |
Version Model Number | HT-TM-5540 |
Catalog Number | HT-TM-5540 |
Company DUNS | 080307067 |
Company Name | FUSION ORTHOPEDICS, LLC |
Device Count | 1 |
DM Exempt | false |
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 | 00852164007278 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00852164007278]
Moist Heat or Steam Sterilization
[00852164007278]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-04-30 |
Device Publish Date | 2019-04-22 |
00852164007032 | Large PIP Implant |
00852164007025 | Medium PIP Implant |
00852164007018 | Small PIP Implant |
00852164007001 | Extra Small PIP Implant |
00852164007407 | PEEK Implant Large |
00852164007391 | PEEK Implant Medium |
00852164007384 | PEEK Implant Small |
00852164007377 | PEEK Implant Extra Small |
00852164007360 | PEEK Implant Petite |
00852164007339 | Ti Implant 10° Angled Large |
00852164007322 | Ti Implant 10° Angled Medium |
00852164007315 | Ti Implant 10° Angled Small |
00852164007308 | Ti Implant 10° Angled Extra Small |
00852164007292 | Ti Implant 10° Angled Petite |
00852164007278 | Ti Implant Medium |
00852164007261 | Ti Implant Small |
00852164007254 | Ti Implant Extra Small |
00852164007247 | Ti Implant Petite |
00819034027460 | HT Ti Angled Driver Petite |
00819034027453 | HT Ti Standard Driver Medium |
00819034027446 | HT Ti Standard Driver Large |
00819034027439 | HT Ti Standard Driver Small |
00819034027248 | HT PEEK Removal Tool |
00819034027231 | HT PEEK Sizer Wheel |
00819034027187 | HT PEEK Calibrated Drill Large |
00819034027170 | HT PEEK Calibrated Drill Medium |
00819034027163 | HT PEEK Calibrated Drill Small |
00819034027156 | HT PEEK Calibrated Drill Extra Small |
00819034027149 | HT PEEK Calibrated Drill Petite |
00819034027132 | HT PEEK Driver Large |
00819034027125 | HT PEEK Driver Medium |
00819034027118 | HT PEEK Driver Small |
00819034027101 | HT PEEK Driver Extra Small |
00819034027095 | HT PEEK Driver Petite |
00819034024872 | HT Ti Standard Driver Extra Small |
00819034024841 | HT Ti Standard Driver Petite |
00852164007988 | Cup and Cone Reamer Implant System 12mm |
00852164007971 | Cup and Cone Reamer Implant System 10mm |
00852164007964 | Cup and Cone Reamer Implant System 8mm |
00852164007957 | Removal Tool PEEK |
00852164007940 | HT Ti Sizer Wheel Titanium |
00852164007933 | HT Ti Sizer Wheel Titanium |
00852164007926 | HT Awl (Single) |
00852164007919 | PEEK Implant Instrument Kit Large |
00852164007902 | HT Sizer Wheel PEEK |
00852164007896 | PEEK Implant Instrument Kit Medium |
00852164007889 | PEEK Implant Instrument Kit Small |
00852164007872 | PEEK Implant Instrument Kit Extra Small |
00852164007865 | PEEK Implant Instrument Kit Petite |
00852164007858 | Large PEEK Implant (Single) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HAMMERTECH 90715358 not registered Live/Pending |
Hammer Technologies Pty Ltd 2021-05-17 |