Cytology Brush 3.0 FR (1.0 mm), 115 cm

GUDID 00821925001442

CYB-3 CYTOLOGY BRUSH 115 CM

Gyrus Acmi, Inc.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 00821925001442
• NIH Device Record Key: a805e6db-b1fa-4be8-b938-d56415bb495b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytology Brush 3.0 FR (1.0 mm), 115 cm
• Version Model Number: CYB-3
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925001442 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902737

FDA Product Code

• FDX: endoscopic cytology brush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-10-13

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