Osteoflex

GUDID 15056033810538

PAN MEDICAL US CORPORATION

Orthopaedic cement, non-medicated

• Primary Device ID: 15056033810538
• NIH Device Record Key: e3feffd7-6985-4823-8d48-6d6d6ab7ad6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osteoflex
• Version Model Number: INTV-CEM
• Company DUNS: 080228535
• Company Name: PAN MEDICAL US CORPORATION
• 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: 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	15056033810538 [Primary]

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-02
• Device Publish Date: 2016-11-04

Devices Manufactured by PAN MEDICAL US CORPORATION

• 15056033811252 - InterV Flex Catheter: 2019-06-13 11 Gauge 15mm Balloon Kyphoplasty Flex Catheter (Mini)
• 15060270904295 - InterV Flex Catheter: 2019-06-13 11 Gauge 20mm Balloon Kyphoplasty Flex Catheter (Mini)
• 15060270907937 - InterV-Curve Plus: 2019-06-13 13 Gauge 15mm Balloon Kyphoplasty Long Catheter (Micro)
• 15060270907944 - InterV-Curve Plus: 2019-06-13 13 Gauge 20mm Balloon Kyphoplasty Long Catheter (Micro)
• 15056033810538 - Osteoflex: 2019-05-02
• 15056033810538 - Osteoflex: 2019-05-02