Puritan Histobrush Cytology Brush 2199

GUDID 30609576250072

Non-sterile Histobrush Cytology Brush. 7" length, plastic handle, soft nylon bristle head.

HARDWOOD PRODUCTS COMPANY LP

Cytology scraper, single-use

• Primary Device ID: 30609576250072
• NIH Device Record Key: 69fa1248-d4e9-4b65-b40a-50285ee1ffce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Puritan Histobrush Cytology Brush
• Version Model Number: Histobrush
• Catalog Number: 2199
• 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	00609576250071 [Unit of Use]
GS1	30609576250072 [Primary]
GS1	50609576250076 [Package]; 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: 2016-05-31

Devices Manufactured by HARDWOOD PRODUCTS COMPANY LP

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• 00609576325021 - CerfiSoft Foam Cytology Collection Swab: 2018-03-29 CerviSoft 7” Sterile Foam Cytology Collection Swab w/Polystyrene Handle - 25-2197