OmniSight™

GUDID M433OS71001

OmniSight Cranial Dynamic Reference Frame Sterile Drape

INTEGRA LIFESCIENCES CORPORATION

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• Primary Device ID: M433OS71001
• NIH Device Record Key: 1e5424c5-3ab9-472e-8d35-4187af4a8f9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OmniSight™
• Version Model Number: OS7100
• Company DUNS: 963856096
• Company Name: INTEGRA LIFESCIENCES CORPORATION
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00381780252880 [Unit of Use]
GS1	10381780252887 [Primary]
HIBCC	M433OS71001 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010548

FDA Product Code

• MMP: Cover, barrier, protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-08-25

On-Brand Devices [OmniSight™]

• M433OS71001: OmniSight Cranial Dynamic Reference Frame Sterile Drape
• M248OTDB1: Drapes, Sterile, OTS
• M433OS2400L1: Versa Tool™ Module, Linux
• 30381780252874: OmniSight™ Reflective Markers 25 Each
• M433OS41101: OmniSight Cranial Dynamic Reference Frame
• M433OS40031: OmniSight Passive Probe Set Sterilization Tray
• M433OS40021: OmniSight Depth Probe, Passive
• M433OS40011: OmniSight Standard Probe, Passive