Neocis Guidance System

GUDID 00810004900011

Draping Kit

NEOCIS INC

Dental stereotactic surgery system

• Primary Device ID: 00810004900011
• NIH Device Record Key: 63defcd5-8426-4282-bc8b-65b8b28a8e44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neocis Guidance System
• Version Model Number: DRW-0730
• Company DUNS: 802312434
• Company Name: NEOCIS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004900011 [Primary]
GS1	10810004900018 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161399

FDA Product Code

• PLV: Dental Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-14
• Device Publish Date: 2019-01-22

On-Brand Devices [Neocis Guidance System]

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