DISPOSABLE CYTOLOGY BRUSH N1077041

GUDID 14953170466028

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 14953170466028
• NIH Device Record Key: 6f276102-a2e1-4fc1-a98f-ba3cc5f96a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DISPOSABLE CYTOLOGY BRUSH
• Version Model Number: BC-203D-2006
• Catalog Number: N1077041
• Company DUNS: 711789789
• Company Name: OLYMPUS MEDICAL SYSTEMS CORP.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx
• Phone: +1(800)401-1086
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170466021 [Primary]
GS1	14953170466028 [Package]; Contains: 04953170466021; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251279

FDA Product Code

• BTG: Brush, Biopsy, Bronchoscope (Non-Rigid)

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: 2025-06-30
• Device Publish Date: 2025-06-20

On-Brand Devices [DISPOSABLE CYTOLOGY BRUSH]

• 14953170152822: DISPOSABLE CYTOLOGY BRUSH
• 14953170059206: DISPOSABLE CYTOLOGY BRUSH
• 14953170049405: DISPOSABLE CYTOLOGY BRUSH
• 14953170049382: DISPOSABLE CYTOLOGY BRUSH
• 14953170049368: DISPOSABLE CYTOLOGY BRUSH
• 14953170049344: DISPOSABLE CYTOLOGY BRUSH
• 14953170042833: DISPOSABLE CYTOLOGY BRUSH
• 14953170042819: DISPOSABLE CYTOLOGY BRUSH
• 14953170042789: BC-17W
• 14953170453806: BC-203D-2006
• 14953170453790: BC-202D-5010
• 14953170453783: BC-202D-3010
• 14953170453776: BC-202D-2010
• 14953170453769: BC-202D-1210
• 14953170453752: BC-201C-1006
• 14953170466028: BC-203D-2006
• 14953170466011: BC-202D-5010
• 14953170466004: BC-202D-3010
• 14953170465991: BC-202D-2010
• 14953170465984: BC-202D-1210