uNion MAX

GUDID 00810076334578

High Angulation Plate, 2-Level, 34 mm

Ulrich Medical Usa, Inc.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00810076334578
NIH Device Record Key1236d19c-733e-45b0-8943-b57778e0f713
Commercial Distribution StatusIn Commercial Distribution
Brand NameuNion MAX
Version Model NumberUU201-02-0034
Company DUNS624083866
Company NameUlrich Medical Usa, Inc.
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com
Phone636-519-0268
Emailinfo@ulrichmedicalusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810076334578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


[00810076334578]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-13
Device Publish Date2024-08-05

On-Brand Devices [uNion MAX]

00814386029469uNion MAX Drill, 2.5 x 24mm
00814386029452uNion MAX Drill, 2.5 x 22mm
00810076337371Screw, Ø4.5 x 24 mm, Self-Tapping Bronze, Fixed
00810076337364Screw, Ø4.5 x 22mm, Self-Tapping Teal, Fixed
00810076337357Screw, Ø4.5 x 20mm, Self-Tapping Green, Fixed
00810076337340Screw, Ø4.5 x 18mm, Self-Tapping Light Blue, Fixed
00810076337333Screw, Ø4.5 x 16mm, Self-Tapping Gold, Fixed
00810076337326Screw, Ø4.5 x 14mm, Self-Tapping Magenta, Fixed
00810076337319Screw, Ø4.5 x 12mm, Self-Tapping Dark Blue, Fixed
00810076337302Screw, Ø4.0 x 24mm, Self-Drilling/Self-Tapping Bronze, Fixed
00810076337296Screw, Ø4.0 x 22mm, Self-Drilling/Self-Tapping Teal, Fixed
00810076337289Screw, Ø4.0 x 20mm, Self-Drilling/Self-Tapping Green, Fixed
00810076337272Screw, Ø4.0 x 18mm, Self-Drilling/Self-Tapping Light Blue, Fixed
00810076337265Screw, Ø4.0 x 16mm, Self-Drilling/Self-Tapping Gold, Fixed
00810076337258Screw, Ø4.0 x 14mm, Self-Drilling/Self-Tapping Magenta, Fixed
00810076337241Screw, Ø4.0 x 12mm, Self-Drilling/Self-Tapping Dark Blue, Fixed
00810076337234Screw, Ø4.5 x 24mm, Self-Drilling Bronze, Fixed
00810076337227Screw, Ø4.5 x 22mm, Self-Drilling Teal, Fixed
00810076337210Screw, Ø4.5 x 20mm, Self-Drilling Green, Fixed
00810076337203Screw, Ø4.5 x 18mm, Self-Drilling Light Blue, Fixed
00810076337197Screw, Ø4.5 x 16mm, Self-Drilling Gold, Fixed
00810076337180Screw, Ø4.5 x 14mm, Self-Drilling Magenta, Fixed
00810076337166Screw, Ø4.0 x 24mm, Self-Drilling Bronze, Fixed
00810076337159Screw, Ø4.0 x 22mm, Self-Drilling Teal, Fixed
00810076337142Screw, Ø4.0 x 20mm, Self-Drilling Green, Fixed
00810076337135Screw, Ø4.0 x 18mm, Self-Drilling Light Blue, Fixed
00810076337128Screw, Ø4.0 x 16mm, Self-Drilling Gold, Fixed
00810076337111Screw, Ø4.0 x 14mm, Self-Drilling Magenta, Fixed
00810076337104Screw, Ø4.0 x 12mm, Self-Drilling Dark Blue, Fixed
00810076337043Sterilization case, Implant Only Tray
00810076337036Sterilization case outer case
00810076337029AO Ratcheting Handle
00810076337012Static Handle
00810076337005AO Jewelers Handle
00810076336992Temporary Fixation Screw
00810076336985Screw, Ø4.5 x 22mm, Self-Drilling Teal, Variable
00810076336978Screw, Ø4.5 x 20mm, Self-Drilling Green, Variable
00810076336961Screw, Ø4.5 x 18mm, Self-Drilling Light Blue, Variable
00810076336954Screw, Ø4.5 x 16mm, Self-Drilling Gold, Variable
00810076336947Screw, Ø4.5 x 14mm, Self-Drilling Magenta, Variable
00810076336930Screw, Ø4.5 x 12mm, Self-Drilling Dark Blue, Variable
00810076336923Screw, Ø4.5 x 24mm, Self-Drilling, Bronze, Variable
00810076335414Spring-Loaded Awl Sleeve
00810076335407Awl Sleeve
00810076335391Awl
00810076335384DTS Guide, 30°
00810076335377DTS Guide, 15°
00810076335254Double Barrel Variable Drill Guide
00810076335247Single Barrel Variable Drill Guide
00810076335223uNion MAX Drill, 2.5 x 20mm

Trademark Results [uNion MAX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
UNION MAX
UNION MAX
98062904 not registered Live/Pending
FocusVape Technology Co.,Limited
2023-06-28

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.