OMNIBotics NS-27016

GUDID 00841690194446

ART Knee Software Rev 2.5.0

Omni Life Science, Inc.

Robotic surgical navigation system application software

• Primary Device ID: 00841690194446
• NIH Device Record Key: e0ba5289-8364-40d0-b60d-bd6ac06f5381
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNIBotics
• Version Model Number: NS-27016
• Catalog Number: NS-27016
• Company DUNS: 061339651
• Company Name: Omni Life Science, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841690194446 [Primary]

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-04
• Device Publish Date: 2023-03-27

On-Brand Devices [OMNIBotics]

• 00841690196075: OMNIBotics, Pin Driver, Zimmer End
• 00841690195429: OMNIBotics Sterilization Tray
• 00841690195412: HLS Sterilization Tray
• 00841690195405: Unity Sterilization Tray
• 00841690194866: OMNIBotics Station Power Cord, UK
• 00841690194859: OMNIBotics Station Power Cord, Switzerland
• 00841690194842: OMNIBotics Station Power Cord, South Africa
• 00841690194835: OMNIBotics Station Power Cord, Israel
• 00841690194811: OMNIBotics Sterilization Tray
• 00841690194804: OMNIBotics CAMERA
• 00841690194736: iBlock Control Box
• 00841690194729: Universal total knee navigation guide
• 00841690194712: ART Knee Software unitary component
• 00841690194705: Technical Core Library
• 00841690194651: Cut Controller with reattachable fixation interface
• 00841690194583: OMNIBotics, Universal Reattachable Array Holder
• 00841690194569: OMNIBotics Marker Kit
• 00841690194552: OMNIBotics Marker Kit
• 00841690194491: OMNIBotics Application System Rev 2.2.0
• 00841690194484: Disk Image for CF53SS
• 00841690194477: Disk Image for CF532S
• 00841690194460: ART Knee Software Rev 2.4.0
• 00841690194453: OMNIBotics Application System Rev 2.3.0
• 00841690194446: ART Knee Software Rev 2.5.0
• 00841690194439: ART Knee Software Rev 2.6.0
• 00841690194422: Software Package, AS 2.3
• 00841690194415: Disk Image for SKU CF-53SSLDY1M Compatible with Vega
• 00841690194408: Disk Image for SKU CF-532SLZyCM Compatible with Vega
• 00841690194392: Software Package, ART Knee 2.7
• 00841690194224: OMNIBotics, Pin Placement Guide
• 00841690194200: OMNIBotics, Pin Placement Guide, Stylus
• 00841690194194: OMNIBotics, Nanoblock V2
• 00841690194187: OMNIBotics, Offset Saw Guide
• 00841690194170: BalanceBot Cable
• 00841690194163: BalanceBot Motor Unit
• 00841690194156: OMNIBotics Knee Instruments for HLS Kneetec Pan
• 00841690194149: OMNIBotics Knee Instruments for Unity Pan
• 00841690194125: OMNIBotics BalanceBot for HLS Kneetec Pan
• 00841690194118: OMNIBotics BalanceBot for Unity Pan
• 00841690194088: OMNIBotics Station Cart
• 00841690194019: Software unitary component (common to hip and knee)
• 00841690193982: Torque Limiting handle 4.5Nm, Zimmer connection
• 00841690193975: Torque Limiting handle 4.5Nm, Hudson connection
• 00841690193968: Two pin universal fixation with 45 deg attachment
• 00841690199991: Nano block
• 00841690199939: Cancellous bone screws Ø5.5mmx50mm
• 00841690199922: Cancellous bone screws Ø5.5mmx70mm
• 00841690199915: cortical bone screw 3.2mm x 80mm
• 00841690199908: cortical bone screw 3.2mm x 110mm
• 00841690199892: Self-tapping and self-drilling bone screw Ø4mm, L150mm, thread 45mm