ADAPT 0101-2900

GUDID 07613327312393

PC Unit

Stryker Leibinger GmbH & Co. KG

Medical image management system

• Primary Device ID: 07613327312393
• NIH Device Record Key: 3fab4b2b-fcb0-47f3-82a3-a9561649a568
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADAPT
• Version Model Number: 0101-2900
• Catalog Number: 0101-2900
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: true
• Serial Number: true
• 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	07613327312393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181848

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• OLO: Orthopedic 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: 2020-02-19
• Device Publish Date: 2018-11-26

On-Brand Devices [ADAPT]

• 07613327312430: PC Set
• 07613327312393: PC Unit