FDA.reportPublic FDA data

Safetex

Primary DI
00187207000238
Brand
Safetex
Company
Andwin Scientific
Model
890076
Device description
"SCRAPER, PLASTIC 8"" SAFETEX DOUBLE ENDED (100)"
Published
2017-11-01
Public version status
Update
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
K983428000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983428000SAFETEX CERVICAL SCRAPER (PLASTIC)Andwin Scientific1998-11-16HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20187207000232PackageGS15In Commercial Distribution
00187207000238PrimaryGS10
10187207000235Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2018720700023220187207000232
00187207000238001872070002381872070002380187207000238
1018720700023510187207000235

GMDN Terms#

Term, Definition table
TermDefinition
Cervical cytology scraper, single-useA hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
028449445
Device count
100
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
30187207000437Andwin Scientific8901872019-05-22
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

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