Papette 892030-P100

GUDID 00187207000269

PAPETTE PAP SMEAR BRUSH, NON-STERILE 8" (100)

Andwin Scientific

Cervical cytology brush

• Primary Device ID: 00187207000269
• NIH Device Record Key: 5f2264e6-995c-4480-a01d-9e11b7933ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Papette
• Version Model Number: 892030
• Catalog Number: 892030-P100
• Company DUNS: 028449445
• Company Name: Andwin Scientific
• 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: 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	00187207000269 [Primary]
GS1	10187207000266 [Unit of Use]
GS1	20187207000263 [Package]; Package: CASE [5 Units]; In Commercial Distribution

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"