Andwin Scientific

GUDID 20187207000164

PAPKIT, (1) Single Frost Slide & Fixative Pouch

Andwin Scientific

Papanicolaou smear kit
Primary Device ID20187207000164
NIH Device Record Keyb9f56de6-5309-44e1-8c35-3778e30b8f6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndwin Scientific
Version Model Number230152
Company DUNS028449445
Company NameAndwin Scientific
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100187207000160 [Primary]
GS110187207000167 [Package]
Contains: 00187207000160
Package: INNER PACK [25 Units]
In Commercial Distribution
GS120187207000164 [Package]
Contains: 10187207000167
Package: CASE [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OHLPap Smear Kit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-02

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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