HammerTech CD-HT-1000-S

GUDID 00840124508170

HT Awl (Single)

FUSION ORTHOPEDICS, LLC

Bone awl, reusable
Primary Device ID00840124508170
NIH Device Record Key7f62e3e9-328c-448b-8ccf-4d9dda3ccc39
Commercial Distribution StatusIn Commercial Distribution
Brand NameHammerTech
Version Model NumberCD-HT-1000-S
Catalog NumberCD-HT-1000-S
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840124508170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWJAwl

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


[00840124508170]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

On-Brand Devices [HammerTech]

00852164007032Large PIP Implant
00852164007025Medium PIP Implant
00852164007018Small PIP Implant
00852164007001Extra Small PIP Implant
00852164007407PEEK Implant Large
00852164007391PEEK Implant Medium
00852164007384PEEK Implant Small
00852164007377PEEK Implant Extra Small
00852164007360PEEK Implant Petite
00852164007339Ti Implant 10° Angled Large
00852164007322Ti Implant 10° Angled Medium
00852164007315Ti Implant 10° Angled Small
00852164007308Ti Implant 10° Angled Extra Small
00852164007292Ti Implant 10° Angled Petite
00852164007278Ti Implant Medium
00852164007261Ti Implant Small
00852164007254Ti Implant Extra Small
00852164007247Ti Implant Petite
00819034027460HT Ti Angled Driver Petite
00819034027453HT Ti Standard Driver Medium
00819034027446HT Ti Standard Driver Large
00819034027439HT Ti Standard Driver Small
00819034027248HT PEEK Removal Tool
00819034027231HT PEEK Sizer Wheel
00819034027187HT PEEK Calibrated Drill Large
00819034027170HT PEEK Calibrated Drill Medium
00819034027163HT PEEK Calibrated Drill Small
00819034027156HT PEEK Calibrated Drill Extra Small
00819034027149HT PEEK Calibrated Drill Petite
00819034027132HT PEEK Driver Large
00819034027125HT PEEK Driver Medium
00819034027118HT PEEK Driver Small
00819034027101HT PEEK Driver Extra Small
00819034027095HT PEEK Driver Petite
00819034024872HT Ti Standard Driver Extra Small
00819034024841HT Ti Standard Driver Petite
00852164007988Cup and Cone Reamer Implant System 12mm
00852164007971Cup and Cone Reamer Implant System 10mm
00852164007964Cup and Cone Reamer Implant System 8mm
00852164007957Removal Tool PEEK
00852164007940HT Ti Sizer Wheel Titanium
00852164007933HT Ti Sizer Wheel Titanium
00852164007926HT Awl (Single)
00852164007919PEEK Implant Instrument Kit Large
00852164007902HT Sizer Wheel PEEK
00852164007896PEEK Implant Instrument Kit Medium
00852164007889PEEK Implant Instrument Kit Small
00852164007872PEEK Implant Instrument Kit Extra Small
00852164007865PEEK Implant Instrument Kit Petite
00852164007858Large PEEK Implant (Single)

Trademark Results [HammerTech]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAMMERTECH
HAMMERTECH
90715358 not registered Live/Pending
Hammer Technologies Pty Ltd
2021-05-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.