Andwin Scientific

GUDID 20187207000362

Andwin 6.5" Brush PK/500

Andwin Scientific

Cervical cytology brush
Primary Device ID20187207000362
NIH Device Record Key6610779d-5358-4e98-828e-243f2d47b44c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndwin Scientific
Version Model Number890182
Company DUNS028449445
Company NameAndwin Scientific
Device Count500
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110187207000341 [Unit of Use]
GS120187207000362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HHTSpatula, Cervical, Cytological

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-30
Device Publish Date2019-05-22

On-Brand Devices [Andwin Scientific]

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

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