WatchTower ROAM

GUDID 04719883200501

Image calibrator-31F

INTAI TECHNOLOGY CORP.

Neurological stereotactic surgery system
Primary Device ID04719883200501
NIH Device Record Key6c76fb27-84ba-4789-aeb4-44c9717fb333
Commercial Distribution StatusIn Commercial Distribution
Brand NameWatchTower ROAM
Version Model NumberSYS-CAL31F
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104719883200501 [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 Date2025-12-04
Device Publish Date2025-11-26

On-Brand Devices [WatchTower ROAM]

04719894320984Spine Surgery Navigation System
04719876732408Image Calibrator with Assembly Kit-12 inch
04719883200501Image calibrator-31F
04719883200495Image calibrator-21F

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