Neocis Guidance System

GUDID 00810004900011

Draping Kit

NEOCIS INC

Dental stereotactic surgery system
Primary Device ID00810004900011
NIH Device Record Key63defcd5-8426-4282-bc8b-65b8b28a8e44
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeocis Guidance System
Version Model NumberDRW-0730
Company DUNS802312434
Company NameNEOCIS INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810004900011 [Primary]
GS110810004900018 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLVDental Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-14
Device Publish Date2019-01-22

On-Brand Devices [Neocis Guidance System]

00810004900103Tracker End Effector, -0 Degrees
00810004900097Chairside Splint, LLUR
00810004900080Chairside Splint, LRUL
00810004900073Anterior Splint, LRUL
00810004900066Anterior Splint, LLUR
00810004900059Anterior Fiducial Array, LLUR
00810004900042Anterior Fiducial Array, LRUL
00810004900035Posterior Fiducial Array, LRUL
00810004900028Posterior Fiducial Array, LLUR
00810004900011Draping Kit
00810004900004Yomi and Accessories Packaged
20810004900008Yomi Accessory Kit
00810004900332LRUL - Anterior Chairside Splint
00810004900325LLUR - Anterior Chairside Splint
00810004900318Prexion 3D Excelsior Chin Rest
00810004900301Yomi and Accessories Packaged - Left Handed Configuration
00810004900271LRUL - Posterior Splint
00810004900264LLUR - Posterior Splint
00810004900257LRUL - Anterior Splint
00810004900240Unified Fiducial Array - LRUL
00810004900233LLUR - Anterior Splint
00810004900226Unified Fiducial Array - LLUR
00810004900202Pax Reve3d Plus Chin Rest
00810004900158i-CAT CBCT Chin Rest
00810004900141Galileos Orthopos Chin Rest
00810004900134Vatach PAX Chin Rest
00810004900127Carestream CS9300 Chin Rest
00810004900110Planmeca Promax Chin Rest
10810004900384Maxilla EPS (Left)
10810004900377Maxilla EPS (Right)
10810004900360Mandible EPS (Right)
10810004900353Mandible EPS (Left)
00810004900400NewTom Scanner Chin Rest
10810004900445LLRUL Posterior C-CPS
10810004900438LLUR Posterior C-CPS
10810004900414LLUR Anterior C-CPS
10810004900421LLRUL Anterior C-CPS
00810004900462KaVo OP 3D Chinrest
00810004900479Rayscan RCT700 Chin Rest
00810004900455Sirona Chin Rest
00810004900394TrackerNeo Draping Kit

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