WatchTower ROAM

GUDID 04719876732408

Image Calibrator with Assembly Kit-12 inch

INTAI TECHNOLOGY CORP.

Neurological stereotactic surgery system
Primary Device ID04719876732408
NIH Device Record Keyd38d40fa-28ca-4a29-b0f6-1aeaad85ded7
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatchTower ROAM
Version Model NumberSYS-CALI12
Company DUNS658683227
Company NameINTAI TECHNOLOGY CORP.
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104719876732408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-16
Device Publish Date2024-05-08

On-Brand Devices [WatchTower ROAM]

04719894320984Spine Surgery Navigation System
04719876732408Image Calibrator with Assembly Kit-12 inch

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