uNion MAX
GUDID 00810076334783
High Angulation Plate, 4-Level, 80 mm
Ulrich Medical Usa, Inc.
Spinal fixation plate, non-bioabsorbable| Primary Device ID | 00810076334783 |
| NIH Device Record Key | e4f88de9-bf11-476b-8c97-4a22fd0dfdf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | uNion MAX |
| Version Model Number | UU201-04-0080 |
| Company DUNS | 624083866 |
| Company Name | Ulrich Medical Usa, Inc. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810076334783 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K240515
FDA Product Code
| KWQ | Appliance, Fixation, Spinal Intervertebral Body |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
[00810076334783]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-13 |
| Device Publish Date | 2024-08-05 |
On-Brand Devices [uNion MAX]
| 00814386029469 | uNion MAX Drill, 2.5 x 24mm |
| 00814386029452 | uNion MAX Drill, 2.5 x 22mm |
| 00810076337371 | Screw, Ø4.5 x 24 mm, Self-Tapping Bronze, Fixed |
| 00810076337364 | Screw, Ø4.5 x 22mm, Self-Tapping Teal, Fixed |
| 00810076337357 | Screw, Ø4.5 x 20mm, Self-Tapping Green, Fixed |
| 00810076337340 | Screw, Ø4.5 x 18mm, Self-Tapping Light Blue, Fixed |
| 00810076337333 | Screw, Ø4.5 x 16mm, Self-Tapping Gold, Fixed |
| 00810076337326 | Screw, Ø4.5 x 14mm, Self-Tapping Magenta, Fixed |
| 00810076337319 | Screw, Ø4.5 x 12mm, Self-Tapping Dark Blue, Fixed |
| 00810076337302 | Screw, Ø4.0 x 24mm, Self-Drilling/Self-Tapping Bronze, Fixed |
| 00810076337296 | Screw, Ø4.0 x 22mm, Self-Drilling/Self-Tapping Teal, Fixed |
| 00810076337289 | Screw, Ø4.0 x 20mm, Self-Drilling/Self-Tapping Green, Fixed |
| 00810076337272 | Screw, Ø4.0 x 18mm, Self-Drilling/Self-Tapping Light Blue, Fixed |
| 00810076337265 | Screw, Ø4.0 x 16mm, Self-Drilling/Self-Tapping Gold, Fixed |
| 00810076337258 | Screw, Ø4.0 x 14mm, Self-Drilling/Self-Tapping Magenta, Fixed |
| 00810076337241 | Screw, Ø4.0 x 12mm, Self-Drilling/Self-Tapping Dark Blue, Fixed |
| 00810076337234 | Screw, Ø4.5 x 24mm, Self-Drilling Bronze, Fixed |
| 00810076337227 | Screw, Ø4.5 x 22mm, Self-Drilling Teal, Fixed |
| 00810076337210 | Screw, Ø4.5 x 20mm, Self-Drilling Green, Fixed |
| 00810076337203 | Screw, Ø4.5 x 18mm, Self-Drilling Light Blue, Fixed |
| 00810076337197 | Screw, Ø4.5 x 16mm, Self-Drilling Gold, Fixed |
| 00810076337180 | Screw, Ø4.5 x 14mm, Self-Drilling Magenta, Fixed |
| 00810076337166 | Screw, Ø4.0 x 24mm, Self-Drilling Bronze, Fixed |
| 00810076337159 | Screw, Ø4.0 x 22mm, Self-Drilling Teal, Fixed |
| 00810076337142 | Screw, Ø4.0 x 20mm, Self-Drilling Green, Fixed |
| 00810076337135 | Screw, Ø4.0 x 18mm, Self-Drilling Light Blue, Fixed |
| 00810076337128 | Screw, Ø4.0 x 16mm, Self-Drilling Gold, Fixed |
| 00810076337111 | Screw, Ø4.0 x 14mm, Self-Drilling Magenta, Fixed |
| 00810076337104 | Screw, Ø4.0 x 12mm, Self-Drilling Dark Blue, Fixed |
| 00810076337043 | Sterilization case, Implant Only Tray |
| 00810076337036 | Sterilization case outer case |
| 00810076337029 | AO Ratcheting Handle |
| 00810076337012 | Static Handle |
| 00810076337005 | AO Jewelers Handle |
| 00810076336992 | Temporary Fixation Screw |
| 00810076336985 | Screw, Ø4.5 x 22mm, Self-Drilling Teal, Variable |
| 00810076336978 | Screw, Ø4.5 x 20mm, Self-Drilling Green, Variable |
| 00810076336961 | Screw, Ø4.5 x 18mm, Self-Drilling Light Blue, Variable |
| 00810076336954 | Screw, Ø4.5 x 16mm, Self-Drilling Gold, Variable |
| 00810076336947 | Screw, Ø4.5 x 14mm, Self-Drilling Magenta, Variable |
| 00810076336930 | Screw, Ø4.5 x 12mm, Self-Drilling Dark Blue, Variable |
| 00810076336923 | Screw, Ø4.5 x 24mm, Self-Drilling, Bronze, Variable |
| 00810076335414 | Spring-Loaded Awl Sleeve |
| 00810076335407 | Awl Sleeve |
| 00810076335391 | Awl |
| 00810076335384 | DTS Guide, 30° |
| 00810076335377 | DTS Guide, 15° |
| 00810076335254 | Double Barrel Variable Drill Guide |
| 00810076335247 | Single Barrel Variable Drill Guide |
| 00810076335223 | uNion MAX Drill, 2.5 x 20mm |
Trademark Results [uNion MAX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 UNION MAX 98062904 not registered Live/Pending |
FocusVape Technology Co.,Limited 2023-06-28 |
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