FDA.reportPublic FDA data

C20310

Primary DI
08809157488028
Brand
C20310
Company
B&B Company Co.,Ltd.
Model
C20310 10P
Published
2023-07-17
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809157488028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809157488028088091574880288809157488028

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
557822347
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809157480251e-sarangMULTIFUNCTIONAL TOOTHBRUSH2023-07-17
08809157481401e-sarangI TYPE INTERDENTAL BRUSH 10P2023-07-17
08809157481517e-sarangI TYPE INTERDENTAL BRUSH S 5P2023-07-17
08809157481524e-sarangI TYPE INTERDENTAL BRUSH M 5PI TYPE INTERDENTAL BRUSH M 5P2023-07-17
08809157481531e-sarang I TYPE INTERDENTAL BRUSH L 5P2023-07-17
08809157481548e-sarangI TYPE INTERDENTAL BRUSH XL 5PI TYPE INTERDENTAL BRUSH XL 5P2023-07-17
08809157482514e-sarangL TYPE INTERDENTAL BRUSH S 5P2023-07-17
08809157482521e-sarangL TYPE INTERDENTAL BRUSH M 5PL TYPE INTERDENTAL BRUSH M 5P2023-07-17
08809157482538e-sarangL TYPE INTERDENTAL BRUSH L 5PL TYPE INTERDENTAL BRUSH L 5P2023-07-17
08809157482545e-sarangL TYPE INTERDENTAL BRUSH XL 5PL TYPE INTERDENTAL BRUSH XL 5P2023-07-17
08809157482750e-sarangREFILLABLE INTERDENTAL BRUSHREFILLABLE INTERDENTAL BRUSH2023-07-17
08809157484013e-sarangTONGUE CLEANER VIOLETTONGUE CLEANER VIOLET2023-07-17
08809157484020e-sarangTONGUE CLEANER YELLOWTONGUE CLEANER YELLOW2023-07-17
08809157484112e-sarangDENTAL FLOSS 840D2023-07-17
08809157484129e-sarangDENTAL FLOSS 630DDENTAL FLOSS 630D2023-07-17
08809157486109e-sarangTRAVEL KITTRAVEL KIT2023-07-17
08809157486215e-sarangWHITECLEARWHITECLEAR2023-07-17
08809157486321e-sarangHAPPINESS SET 3HAPPINESS SET 32023-07-17
08809157486338e-sarangHAPPINESS SET 3HAPPINESS SET 32023-07-17
08809157488011C20310C20310 1P2023-07-17

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
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
18719189246220Rovers® Viba-Brush®Rovers Medical Devices B.V.HHT2023-07-12