ExoCube

GUDID 08685139210012

EXOCUBE BIYOTEKNOLOJI ANONIM SIRKETI

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 08685139210012
• NIH Device Record Key: 8734139b-53cb-4b93-92a5-4e34753a6a65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ExoCube
• Version Model Number: 1
• Company DUNS: 751242258
• Company Name: EXOCUBE BIYOTEKNOLOJI ANONIM SIRKETI
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08685139210012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK251196

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: 2026-03-23
• Device Publish Date: 2026-03-15

Devices Manufactured by EXOCUBE BIYOTEKNOLOJI ANONIM SIRKETI

• 08685139210012 - ExoCube: 2026-03-23
• 08685139210012 - ExoCube: 2026-03-23
• 08685139210029 - Exocube Set: 2026-03-23
• 08685139210043 - Exocube Kit: 2026-03-23
• 08685139210050 - Centrifuge Container Kit 60-10Pack: 2026-03-23
• 08685139210067 - ExoCube-20Pack: 2026-03-23
• 08685139210074 - ExoCube Kit 60-10P: 2026-03-23
• 08685139210081 - ExoCube Kit 120-10P: 2026-03-23
• 08685139210098 - ExoCube Kit 60: 2026-03-23