OsOpia

GUDID 08720165038091

OsOpia Granules 2cc 0.25-1mm

RevisiOs B.V.

Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite Bone matrix implant, composite 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