Andwin Scientific

GUDID 00187207000382

Andwin 7.5" Brush PK/100

Andwin Scientific

Cervical cytology brush
Primary Device ID00187207000382
NIH Device Record Key082f5a4b-f023-4d1a-9aad-daafa0061e47
Commercial Distribution StatusIn Commercial Distribution
Brand NameAndwin Scientific
Version Model Number890183
Company DUNS028449445
Company NameAndwin Scientific
Device Count100
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
GS100187207000382 [Primary]
GS110187207000372 [Unit of Use]

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]

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20187207000195PAPKIT, 5035X, 2 Slide, Brush, Scraper, CTA & Fix Pouch
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20187207000164PAPKIT, (1) Single Frost Slide & Fixative Pouch
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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
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20187207000362Andwin 6.5" Brush PK/500
00187207000412Andwin 7.5" Snap-off Brush PK/50
00187207000382Andwin 7.5" Brush PK/100

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