FDA.reportPublic FDA data

Puritan Histobrush Cytology Brush

Primary DI
30609576250072
Brand
Puritan Histobrush Cytology Brush
Company
Puritan Medical Products
Model
Histobrush
Catalog number
2199
Device description
"Non-sterile Histobrush Cytology Brush. 7"" length, plastic handle, soft nylon bristle head."
Published
2016-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50609576250076PackageGS11000In Commercial Distribution
30609576250072PrimaryGS10
00609576250071Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060957625007650609576250076
3060957625007230609576250072
00609576250071006095762500716095762500710609576250071

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10609576330763Puritan HydraFlock25-3806-H BT25-3806-H BT2022-12-08
10609576330770Puritan PurFlock Ultra25-3806-U BT25-3806-U BT2022-12-08
10609576330787Puritan PurFlock Ultra25-3316-H BT25-3316-H BT2022-12-08
10609576330794Puritan PurFlock Ultra25-3316-U BT25-3316-U BT2022-12-08
10609576330800Puritan HydraFlock25-3317-H BT25-3317-H BT2022-12-08
10609576330916Puritan HydraFlock25-3316-H EMB 80 BT25-3316-H EMB 80 BT2022-12-08
10609576330923Puritan HydraFlock25-3316-H EMB 100 BT25-3316-H EMB 100 BT2022-12-08
10609576330930Puritan PurFlock Ultra25-3316-U EMB 80 BT25-3316-U EMB 80 BT2022-12-08
10609576331166Puritan HydraFlock25-3706-H BT PK25-3706-H BT PK2022-12-08
10609576331197Puritan HydraFlock25-3206-H 20MM BT25-3206-H 20MM BT2022-12-08
10609576331241Puritan HydraFlock25-3319-H BT25-3319-H BT2022-12-08
10609576331340Puritan HydraFlock25-3806-H BT PK25-3806-H BT PK2022-12-08
10609576370783Puritan PurFlock Ultra25-3706-U BT25-3706-U BT2022-12-08
10609576381710Puritan25-1506 1PF BT BL25-1506 1PF BT BL2022-12-08
30609576900007Puritan UniTranz-RTUT-100UT-1002022-12-08
30609576900014Puritan UniTranz-RTUT-300UT-3002022-12-08
30609576900021Puritan UniTranz-RTUT-106UT-1062022-12-08
30609576900038Puritan UniTranz-RTUT-116UT-1162022-12-08
30609576900045Puritan UniTranz-RTUT-117UT-1172022-12-08
30609576900052Puritan UniTranz-RTUT-306UT-3062022-12-08

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