Safetex

GUDID 00187207000238

SCRAPER, PLASTIC 8" SAFETEX DOUBLE ENDED (100)

Andwin Scientific

Cervical cytology scraper, single-use

• Primary Device ID: 00187207000238
• NIH Device Record Key: dd066217-d2cf-4c30-8054-867a873997d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safetex
• Version Model Number: 890076
• 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	00187207000238 [Primary]
GS1	10187207000235 [Unit of Use]
GS1	20187207000232 [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

Devices Manufactured by Andwin Scientific

• 00187207000351 - Andwin: 2019-05-30 Andwin 6.5" Brush PK/100
• 00187207000382 - Andwin Scientific: 2019-05-30 Andwin 7.5" Brush PK/100
• 00187207000412 - Andwin Scientific: 2019-05-30 Andwin 7.5" Snap-off Brush PK/50
• 20187207000362 - Andwin Scientific: 2019-05-30 Andwin 6.5" Brush PK/500
• 20187207000393 - Andwin Scientific: 2019-05-30 Andwin 7.5" Brush PK/500
• 20187207000423 - Andwin Scientific: 2019-05-30 Andwin 7.5" Snap-off Brush PK/100
• 30187207000437 - Andwin Scientific: 2019-05-30 Andwin 7.5" Snap-off Brush PK/500
• 00187207000078 - Andwin Scientific: 2018-07-06 PAPKIT, 1 SLIDE, BRUSH AND PLASTIC SCRAPER