CTR-S

GUDID 08800204900012

CTCELLS, Inc.

Cell centrifugation/density gradient separation reagent IVD

• Primary Device ID: 08800204900012
• NIH Device Record Key: 6570c797-b362-436e-bcad-c46097ec136c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CTR-S
• Version Model Number: CTUK-CSP103
• Company DUNS: 963366615
• Company Name: CTCELLS, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	08800204900012 [Primary]

FDA Product Code

• GKH: Apparatus, Automated Blood Cell Diluting

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: 2025-03-27
• Device Publish Date: 2025-03-19

Devices Manufactured by CTCELLS, Inc.

• 08800204900005 - CTCeptor: 2025-03-27
• 08800204900012 - CTR-S: 2025-03-27
• 08800204900012 - CTR-S: 2025-03-27
• 08800204900029 - CTCD: 2025-03-27