FDA.reportPublic FDA data

Histobrush® Cytology Brush

Primary DI
50609576250083
Brand
Histobrush® Cytology Brush
Company
HARDWOOD PRODUCTS COMPANY LP
Model
2188
Catalog number
2188
Device description
Histobrush 8” Soft Tapered Nylon Bristles Cytology Brush w/Polystyrene Handle - 2188
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K111681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111681000HISTOBRUSHPuritan Medical Products Company, LLC2012-01-19HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50609576250083PackageGS11000In Commercial Distribution
30609576250089PrimaryGS10
00609576250088Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060957625008350609576250083
3060957625008930609576250089
00609576250088006095762500886095762500880609576250088

GMDN Terms#

Term, Definition table
TermDefinition
Cytology scraper, single-useA wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001101419
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50609576250069CerfiSoft Foam Cytology Collection Swab219721972016-09-07

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