Primary Device ID | 00810135960007 |
NIH Device Record Key | c35a3eb3-bd7f-41f8-9c57-78fbffb7c234 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EARP Interbody System |
Version Model Number | EARP1425-0008 |
Company DUNS | 047486041 |
Company Name | NVISION BIOMEDICAL TECHNOLOGIES, 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 |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Depth | 14 Millimeter |
Width | 25 Millimeter |
Height | 8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810135960007 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
[00810135960007]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-11-02 |
Device Publish Date | 2023-10-25 |
00810135962377 - Trigon | 2025-08-04 6mmx30mm radius PEEK small standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for int |
00810135962384 - Trigon | 2025-08-04 6mmx30mm radius PEEK large standard midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for int |
00810135962391 - Trigon | 2025-08-04 6mmx70mm radius PEEK small wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for interna |
00810135962407 - Trigon | 2025-08-04 6mmx70mm radius PEEK large wide midfoot wedge The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for interna |
00810135962834 - Vertex | 2025-08-04 Instrument: 3.0mm Drill. The Vertex Nitinol Staple System consists of a series of nickel titanium alloy staple implants and th |
00810135962865 - Trigon | 2025-08-04 Midfoot Wedge Standard Screw Targeting Guide Assembly The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for |
00810135962889 - Trigon | 2025-08-04 Midfoot Wedge Kwire Sleeve The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for |
00810135962896 - Trigon | 2025-08-04 Midfoot Wedge Staple Drill Guide The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixati |