Andwin Scientific

GUDID 20187207000195

PAPKIT, 5035X, 2 Slide, Brush, Scraper, CTA & Fix Pouch

Andwin Scientific

Papanicolaou smear kit

• Primary Device ID: 20187207000195
• NIH Device Record Key: 80eb6fa6-2cf7-4d09-b231-b9bc3cc0626f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Andwin Scientific
• Version Model Number: 240080
• Company DUNS: 028449445
• Company Name: Andwin Scientific
• 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: true
• 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	00187207000191 [Primary]
GS1	10187207000198 [Package]; Contains: 00187207000191; Package: INNER PACK [25 Units]; In Commercial Distribution
GS1	20187207000195 [Package]; Contains: 10187207000198; Package: CASE [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K890283

FDA Product Code

• OHL: Pap Smear Kit

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: 2017-08-02

On-Brand Devices [Andwin Scientific]

• 00187207000283: BRUSH 8" W/BLACK BRISTLES
• 00187207000276: BRUSH 8" SCORED
• 00187207000245: CYTOLOGY BRUSH W/ WHITE BRISTLES, 6.5"
• 10187207000204: PAPBAG, 1 Slide in PP Mailer, Rovers Broom & Prefilled Pap Jar
• 20187207000195: PAPKIT, 5035X, 2 Slide, Brush, Scraper, CTA & Fix Pouch
• 20187207000188: PAPKIT, CLASSIC, 5010xcpsc, 1 Slide, Brush, 2181 Scraper & Fix Pouch
• 20187207000171: PAPKIT, 5012X, 1 Slide, Scraper, Swab & Fix Pouch
• 20187207000164: PAPKIT, (1) Single Frost Slide & Fixative Pouch
• 20187207000157: PAPKIT, 7000X, 1mm Slide & Rover Broom
• 20187207000140: PAPKIT, 6000 XSF, 1 Super Frosted Slide, Scraper, Brush & 1oz Fixative Bottle
• 20187207000133: PAPKIT, 1 Slide, Scraper, Brush and Fixative Pump
• 20187207000126: PAPKIT, 5010X, 1 Slide, Scraper & Brush
• 20187207000102: PAPKIT, 5030X, 1 Slide, Scraper, Brush, CTA & Fixative Pouch
• 20187207000096: PAPKIT, 5053X,1 Slide, Scraper, Brush & Fixative Pouch
• 20187207000089: PAPKIT, CLASSIC, 5053xcp, 1 Slide, Scraper, Brush & Fixative Pack
• 00187207000078: PAPKIT, 1 SLIDE, BRUSH AND PLASTIC SCRAPER
• 30187207000437: Andwin 7.5" Snap-off Brush PK/500
• 20187207000423: Andwin 7.5" Snap-off Brush PK/100
• 20187207000393: Andwin 7.5" Brush PK/500
• 20187207000362: Andwin 6.5" Brush PK/500
• 00187207000412: Andwin 7.5" Snap-off Brush PK/50
• 00187207000382: Andwin 7.5" Brush PK/100