Single Use Cytology Brush BC-205D

GUDID 14953170401968

Single Use Cytology Brush BC-205D

OLYMPUS MEDICAL SYSTEMS CORP.

Flexible endoscopic cytology brush, single-use

• Primary Device ID: 14953170401968
• NIH Device Record Key: 186c68bb-9721-4eca-a4d0-0d1e90125930
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Single Use Cytology Brush BC-205D
• Version Model Number: BC-205D-2010
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04953170401961 [Primary]
GS1	14953170401968 [Package]; Contains: 04953170401961; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190293
• Premarket Notification: K212667

FDA Product Code

• BTG: Brush, biopsy, bronchoscope (non-rigid)
• EOQ: Bronchoscope (Flexible Or Rigid)

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: 2021-12-17
• Device Publish Date: 2019-08-19

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• 04953170465963 - ENDOSCOPIC CO2 REGULATION UNIT: 2024-12-03
• 04953170465970 - EVIS EXERA III XENON LIGHT SOURCE: 2024-12-03
• 04953170454141 - VISERA S VIDEO SYSTEM CENTER: 2024-11-22
• 04953170452475 - EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE: 2024-10-14
• 04953170464935 - THUNDERBEAT 5 mm, 45 cm, Pistol Grip: 2024-09-17
• 04953170464973 - THUNDERBEAT 5 mm, 35 cm, Inline Grip: 2024-09-17