Histobrush® Cytology Brush 2188

GUDID 50609576250083

Histobrush 8” Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 2188

HARDWOOD PRODUCTS COMPANY LP

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• Primary Device ID: 50609576250083
• NIH Device Record Key: fc6b8523-5e6c-4180-8df0-74b16cde9fcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Histobrush® Cytology Brush
• Version Model Number: 2188
• Catalog Number: 2188
• Company DUNS: 001101419
• Company Name: HARDWOOD PRODUCTS COMPANY LP
• Device Count: 100
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00609576250088 [Unit of Use]
GS1	30609576250089 [Primary]
GS1	50609576250083 [Package]; Contains: 30609576250089; Package: [1000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111681

FDA Product Code

• HHT: Spatula, Cervical, Cytological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-07

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