Papette 892030-P25

GUDID 00187207000252

PAPETTE PAP SMEAR BRUSH, NON-STERILE, 8"

Andwin Scientific

Cervical cytology brush

• Primary Device ID: 00187207000252
• NIH Device Record Key: 19c708ec-43b8-4d87-ad90-79c201ad9da8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Papette
• Version Model Number: 892030
• Catalog Number: 892030-P25
• Company DUNS: 028449445
• Company Name: Andwin Scientific
• Device Count: 25
• 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: false
• 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	00187207000252 [Primary]
GS1	10187207000259 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983428

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: 2017-11-01

On-Brand Devices [Papette]

• 00187207000269: PAPETTE PAP SMEAR BRUSH, NON-STERILE 8" (100)
• 00187207000252: PAPETTE PAP SMEAR BRUSH, NON-STERILE, 8"