Celling ART PRP 2-Step 1601W-0001

GUDID 00817771029525

ART PRP 2-Step Device with SightWheel

Celling Biosciences

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: 00817771029525
• NIH Device Record Key: 4b3b7281-3a1c-46a1-b69a-923cced1a4a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Celling ART PRP 2-Step
• Version Model Number: 1601W-0001
• Catalog Number: 1601W-0001
• Company DUNS: 021560394
• Company Name: Celling Biosciences
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com
• Phone: 512-206-0770
• Email: customerservice@cellingbiosciences.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817771029525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK150221

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: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [Celling ART PRP 2-Step]

• 00817771029525: ART PRP 2-Step Device with SightWheel
• 00817771029174: ART PRP 2-Step Device