CYTO-PAK ASY0056

GUDID 00860011506331

Cyto-Pak Brush Sterile CP-5B

Medical Packaging Corporation

General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 00860011506331
• NIH Device Record Key: 03b9221f-d381-4667-8bcc-8f3b1b97e122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CYTO-PAK
• Version Model Number: CP-5B
• Catalog Number: ASY0056
• Company DUNS: 074133398
• Company Name: Medical Packaging Corporation
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011506331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864323

FDA Product Code

• HHT: Spatula, Cervical, Cytological

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: 2026-02-26
• Device Publish Date: 2026-02-18

Devices Manufactured by Medical Packaging Corporation

• 00860011506300 - CytoSoft: 2026-02-26 Sterile Cytology Brush CYB-1
• 00860011506324 - CytoSoft: 2026-02-26 Non-sterile Cytology Brush CYB-100
• 00860011506331 - CYTO-PAK: 2026-02-26Cyto-Pak Brush Sterile CP-5B
• 00860011506331 - CYTO-PAK: 2026-02-26 Cyto-Pak Brush Sterile CP-5B
• 00860011506348 - SWAB-PAK: 2026-02-26 SWAB-PAK Sterile SP-7D
• 00860011506355 - SWAB-PAK: 2026-02-26 SWAB-PAK Sterile SP-2D