Orthozon 5.1.3.000S

GUDID 10850003355266

Mantis Flex-Cam Drape

EXACT MEDICAL MANUFACTURING, INC.

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• Primary Device ID: 10850003355266
• NIH Device Record Key: 29e65c55-cff6-4541-8149-b05b1d4fea4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthozon
• Version Model Number: 5.1.3.000S
• Catalog Number: 5.1.3.000S
• Company DUNS: 014464314
• Company Name: EXACT MEDICAL MANUFACTURING, 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: 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850003355269 [Primary]
GS1	10850003355266 [Package]; Contains: 00850003355269; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101598

FDA Product Code

• KKX: Drape, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-14

On-Brand Devices [Orthozon]

• 10850003355266: Mantis Flex-Cam Drape
• 00850024023406: Mantis Imaging Station Drape