Transcend PRP

GUDID 14719875912242

AEON BIOTHERAPEUTICS CORP.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 14719875912242
• NIH Device Record Key: 04ff3a1e-3b69-458f-bf2a-be33608477bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcend PRP
• Version Model Number: TP0100
• Company DUNS: 656153288
• Company Name: AEON BIOTHERAPEUTICS CORP.
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719875912245 [Primary]
GS1	14719875912242 [Package]; Contains: 04719875912245; Package: carton [40 Units]; In Commercial Distribution
GS1	94719875912248 [Package]; Contains: 04719875912245; Package: carton [20 Units]; In Commercial Distribution

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: 2025-08-15
• Device Publish Date: 2025-08-07

On-Brand Devices [Transcend PRP]

• 14719875912259: TP0300
• 14719875912242: TP0100