Precise

GUDID M896AMS500350560

Precise Separation Canister, 120 mL

ARTERIOCYTE MEDICAL SYSTEMS, INC.

Haematological concentrate system preparation kit, platelet concentration

• Primary Device ID: M896AMS500350560
• NIH Device Record Key: 38223c3d-d379-45df-946f-8e7651190075
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise
• Version Model Number: AMS50035-056
• Company DUNS: 809012870
• Company Name: ARTERIOCYTE MEDICAL SYSTEMS, INC.
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M896AMS500350560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK200540

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: 2023-06-07
• Device Publish Date: 2023-05-30

On-Brand Devices [Precise ]

• M896AMS500350560: Precise Separation Canister, 120 mL
• M896AMS500350530: Precise Separation Canister, 120 mL
• M896AMS500350500: Precise Separation Canister, 120 mL
• M896AMS500220560: Precise Separation Canister, 60 mL
• M896AMS500220530: Precise Separation Canister, 60mL
• M896AMS500220500: Precise Separation Canister, 60 mL