Primary Device ID | 00868579000230 |
NIH Device Record Key | b6d3e4bb-081f-4958-8107-6072c66e9ba2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VMA Image Acquisition Software |
Version Model Number | 3 |
Company DUNS | 932053221 |
Company Name | ORTHO KINEMATICS, 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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM | |
Phone | 5123345490 |
INFO@ORTHOKINEMATICS.COM |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00868579000230 [Primary] |
LLZ | System, Image Processing, Radiological |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-05-23 |
Device Publish Date | 2017-12-12 |
00868579000216 - VMA DataLink Software | 2019-05-23 |
00868579000223 - VMA DataLink Software | 2019-05-23 VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site |
00868579000230 - VMA Image Acquisition Software | 2019-05-23VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console) |
00868579000230 - VMA Image Acquisition Software | 2019-05-23 VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console) |
00868579000261 - Profile-ESP Bolster | 2019-03-11 The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA S |
00868579000278 - Profile-ESP Radiographic marker | 2019-03-11 The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate |
00868579000209 - VMA | 2019-02-21 |
00868579000247 - VMA Motion Normalizer | 2019-02-21 VMA Motion Normalizer (Console, Table, and Upright assemblies) |