VERASENSE for Zimmer Biomet Persona ZBH-PSNCRCD39-R

GUDID 00816818021485

ORTHOSENSOR INC

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• Primary Device ID: 00816818021485
• NIH Device Record Key: 7a129cfe-b620-452d-b20a-3d4b1fc55e1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERASENSE for Zimmer Biomet Persona
• Version Model Number: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig
• Catalog Number: ZBH-PSNCRCD39-R
• Company DUNS: 005788130
• Company Name: ORTHOSENSOR 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: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816818021485 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180459

FDA Product Code

• ONN: Intraoperative Orthopedic Joint Assessment Aid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2020-11-18

On-Brand Devices [VERASENSE for Zimmer Biomet Persona]

• 00816818021522: VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Ri
• 00816818021515: VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Le
• 00816818021508: VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Ri
• 00816818021492: VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Le
• 00816818021485: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Rig
• 00816818021478: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Lef