spineEOS

GUDID 03663999000160

EOS IMAGING

Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software Orthopaedic/craniofacial implantation planning software

Primary Device ID	03663999000160
NIH Device Record Key	09e7bb95-c0aa-439c-ae4c-5e0583689e4d
Commercial Distribution Status	In Commercial Distribution
Brand Name	spineEOS
Version Model Number	1.2
Company DUNS	762320968
Company Name	EOS IMAGING
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	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

Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com
Phone	8669335301
Email	contact@eos-imaging.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663999000160 [Primary]

FDA Product Code

LLZ	System, Image Processing, Radiological

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-07-18
Device Publish Date	2023-07-10

On-Brand Devices [spineEOS]

03663999000160	1.2
03663999000184	3.0