StatLab

GUDID 16971317521766

Cervical Papette Cell Collector

Yancheng Huida Medical Instruments Co., Ltd.

General-purpose cytology brush

• Primary Device ID: 16971317521766
• NIH Device Record Key: ec42da8c-5f53-4ae2-a161-1953fbdb7f32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StatLab
• Version Model Number: CB400-100
• Company DUNS: 543621553
• Company Name: Yancheng Huida Medical Instruments Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	06971317521769 [Primary]
GS1	16971317521766 [Package]; Contains: 06971317521769; Package: Box [100 Units]; In Commercial Distribution
GS1	26971317521763 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Product Code

• GEE: Brush, Biopsy, General & Plastic Surgery

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: 2024-05-09
• Device Publish Date: 2024-05-01

On-Brand Devices [StatLab]

• 16971317521773: Cervical brush, sterile, scored
• 16971317521766: Cervical Papette Cell Collector
• 16971317522343: Sterile Microscope Slides Frosted Tab
• 16971317522336: Sterile Microscope Slides Frosted Tab
• 16971317522329: Sterile Microscope Slides Yellow Tab
• 16971317522312: Sterile Microscope Slides White Tab