Anatase

GUDID 04719876737083

Guiding AWL-R

INTAI TECHNOLOGY CORP.

Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system Orthopaedic stereotactic surgery system
Primary Device ID04719876737083
NIH Device Record Key7895716c-bdd7-4666-b834-f2f5207cbcae
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnatase
Version Model NumberINS-GUIAWL
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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
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
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
Phone(561) 277-9480
Emailinfo@captivaspine.com
Phone(561) 277-9480
Emailinfo@captivaspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104719876737083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


[04719876737083]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-02-10
Device Publish Date2023-01-30

On-Brand Devices [Anatase]

04719876757807Spine Surgery Navigation System
04719876737274Probe
04719876737267Spine Clamp with DRF
04719876737106Instrument Calibrator V Block
04719876737090Drill Guide
04719876737083Guiding AWL-R
04719876732460Drill Bit
04719876732453Guide Pin 540L
04719876732446Releaser
04719876732439Hex Key Wrench #3
04719876732422Hex Key Wrench #2
04719876732415Post Wrench
04719876732347Palm Awl
04719876732330T Ratchet Handle
04719876732323Spine pin with DRF

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