World PRP

GUDID 00754016214127

Luvo Medical Technologies Inc

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00754016214127
• NIH Device Record Key: 08aeddb4-6972-4076-a3e0-26ad2a712f12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World PRP
• Version Model Number: WORLDPRP
• Company DUNS: 204046564
• Company Name: Luvo Medical Technologies Inc
• Device Count: 10
• 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: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00754016214127 [Unit of Use]
GS1	10754016214124 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK210558

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-19
• Device Publish Date: 2021-08-11

Devices Manufactured by Luvo Medical Technologies Inc

• 00754016214134 - Darwin: 2022-10-24
• 00754016214158 - Darwin IPL Handpiece: 2022-10-24
• 00754016214165 - Darwin Diode Laser Handpiece: 2022-10-24
• 00754016214172 - RF Microneedling Handpiece: 2022-10-24
• 00754016214189 - Darwin RF Thermal: 2022-10-24
• 00754016214127 - World PRP: 2021-08-19
• 00754016214127 - World PRP: 2021-08-19
• 00754016214028 - Bare 808: 2021-06-10
• 00754016214035 - BARE: 808 HANDPIECE: 2021-06-10