OsOpia

GUDID 08720165038091

OsOpia Granules 2cc 0.25-1mm

RevisiOs B.V.

Bone matrix implant, composite

• Primary Device ID: 08720165038091
• NIH Device Record Key: 4768812a-4a2f-453b-b1f4-b0a847d5d202
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OsOpia
• Version Model Number: 702-023-US
• Company DUNS: 489274404
• Company Name: RevisiOs B.V.
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com
• Phone: +31307400500
• Email: marcel.borger@kurosbio.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08720165038091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201546

FDA Product Code

• LYC: Bone grafting material, synthetic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-08
• Device Publish Date: 2021-06-30

On-Brand Devices [OsOpia]

• 08720165038107: OsOpia Granules 5cc 1.25-1mm
• 08720165038091: OsOpia Granules 2cc 0.25-1mm
• 08720165038077: OsOpia Granules 0.5cc 0.25-1mm
• 08720165038084: OsOpia Granules 1cc 0.25-1mm