Primary Device ID | 00852164007179 |
NIH Device Record Key | 74c76629-438b-4f23-a153-c3d87f925255 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HammerTech™ Fixation System |
Version Model Number | HT-10-1150-S1 |
Catalog Number | HT-10-1150-S1 |
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 | 00852164007179 [Primary] |
HWC | Screw, Fixation, Bone |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-11-15 |
00852164007209 | Reaming Implant Kit 12mm |
00852164007193 | Reaming Implant Kit 10mm |
00852164007186 | Reaming Implant Kit 8mm |
00852164007179 | Large PIP Implant Single |
00852164007162 | Medium PIP Implant Single |
00852164007155 | Small PIP Implant Single |
00852164007148 | Extra Small PIP Implant Single |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HAMMERTECH 90715358 not registered Live/Pending |
Hammer Technologies Pty Ltd 2021-05-17 |