FDA.reportPublic FDA data

Andwin Scientific

Primary DI
30187207000437
Brand
Andwin Scientific
Company
Andwin Scientific
Model
890187
Device description
"Andwin 7.5"" Snap-off Brush PK/500 "
Published
2019-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HHTSpatula, Cervical, Cytological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHTSpatula, Cervical, CytologicalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K924908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K924908000CELL COLLECTING BRUSHAnderson Winn Paper Co.1993-04-13HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30187207000437PrimaryGS10
10187207000402Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3018720700043730187207000437
1018720700040210187207000402

GMDN Terms#

Term, Definition table
TermDefinition
Cervical cytology brushA device with bristle-like projections designed to obtain a cervical biopsy of a suspicious area or visible exocervical lesions detected during a vaginal examination for the purpose of obtaining a tissue diagnosis from a woman with intraepithelial disease. It is inserted into the vagina and the head of the brush is firmly rotated over the area of interest until is covered with a bloody-mucoid sample. Some types may also have small bristles on a central protrusion that simultaneously enters the endocervical canal. The sample is secured in a cytology fixation solution or smeared onto a microscope slide for a Papanicolaou test (PAP). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028449445
Device count
500
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00187207000467SealSafe760024P2025-08-14
00187207000474SealSafe760024S2025-08-14
00187207000481SealSafe760020P2025-08-14
00187207000498SealSafe760020S2025-08-14
00187207000504SealSafe760028P2025-08-14
00187207000511SealSafe760028S2025-08-14
00187207000351Andwin 8901812019-05-22
00187207000382Andwin Scientific8901832019-05-22
00187207000412Andwin Scientific8901852019-05-22
20187207000362Andwin Scientific8901822019-05-22
20187207000393Andwin Scientific8901842019-05-22
20187207000423Andwin Scientific8901862019-05-22
00187207000085Andwin Scientific2310572017-08-02
00187207000092Andwin Scientific2301102017-08-02
00187207000108Andwin Scientific2301002017-08-02
00187207000122Andwin Scientific2301802017-08-02
00187207000139Andwin Scientific2300802017-08-02
00187207000146Andwin Scientific2300752017-08-02
00187207000153Andwin Scientific2301602017-08-02
00187207000160Andwin Scientific2301522017-08-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011506300CytoSoftMedical Packaging CorporationHHT2026-02-18
00860011506324CytoSoftMedical Packaging CorporationHHT2026-02-18
00860011506331CYTO-PAKMedical Packaging CorporationHHT2026-02-18
07898027908460KOLPLASTKolplast C IHHT2023-11-29
08809157488011C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488028C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488035C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488042C20310B&B Company Co.,Ltd.HHT2023-07-17
08809157488110C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488127C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488134C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488141C21150B&B Company Co.,Ltd.HHT2023-07-17
08809157488219C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488226C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488233C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488240C27024B&B Company Co.,Ltd.HHT2023-07-17
08809157488318C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488325C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488332C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488349C27632B&B Company Co.,Ltd.HHT2023-07-17
08809157488417C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488424C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488431C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488448C29000B&B Company Co.,Ltd.HHT2023-07-17
08809157488516C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488523C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488530C60100B&B Company Co.,Ltd.HHT2023-07-17
08809157488547C60100B&B Company Co.,Ltd.HHT2023-07-17
18719189246084Rovers® Cervex-Brush® CombiRovers Medical Devices B.V.HHT2023-07-12
18719189246213Rovers® Viba-Brush®Rovers Medical Devices B.V.HHT2023-07-12