FDA.reportPublic FDA data

Cytology Brush

Primary DI
00813360023035
Brand
Cytology Brush
Company
TEAM TECHNOLOGIES, INC.
Model
1
Device description
"8"" Cytology Brush"
Published
2016-09-21
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
K971849000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971849000CYTOLOGY BRUSHTeam Technologies, Inc.1997-07-24HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813360023032PackageGS11000In Commercial Distribution
20813360023039PackageGS11000In Commercial Distribution
30813360023036PackageGS16000In Commercial Distribution
00813360023035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002303210813360023032
2081336002303920813360023039
3081336002303630813360023036
00813360023035008133600230358133600230350813360023035

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
078550672
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813360023233DoselogixTC5-A-BLUE7557452026-05-05
00813360023639DoselogixTC5-A-LSPR-3.5ML 6.5ML Micro7557752026-03-24
00813360023240DoselogixTC5-A-RED7557472025-06-05
00813360023257DoselogixTC5-A-BLUE7557482025-06-05
00813360023226DoselogixTC9-A-LIGHTSAFE-6.5ML ANGLED7557432025-05-12
00813360023189DoselogixTC35-CRTC35-CR-BLUE2025-08-01
00813360023196DoselogixTC35-CRTC35-CR-PINK2025-08-01
00813360023202DoselogixTC35-CRTC35-CR-GREY2025-08-01
00813360023219DoselogixTC35-CRTC35-CR-White2025-08-01
00813360023172DoselogixDOSE LOGIX TC5-A-RED 3.5ML7557412025-04-21
00813360023158DoselogixTC35-CHKTC35-CHK-BLUE2025-02-25
00813360023165DoselogixTC35-CHKTC35-CHK-PINK2025-02-25
00813360023554DoselogixTC9-A-BLUE 3.5ML Micro7556232024-08-13
00813360023561DoselogixTC9-A-BLUE 6.5ML Micro7556242024-08-13
00813360023578DoselogixTC9-A-LIGHTSAFE 3.5ML Micro7556252024-08-13
00813360023585DoselogixTC9-A-LIGHTSAFE 6.5ML Micro7556262024-08-13
00813360023592DoselogixTC9-R-BLUE 3.5ML Micro7556272024-08-13
00813360023608DoselogixTC9-R-BLUE 6.5ML Micro7556282024-08-13
00813360023615DoselogixTC9-R-LIGHTSAFE 3.5ML Micro7556292024-08-13
00813360023622DoselogixTC9-R-LIGHTSAFE 6.5ML Micro7556302024-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011506300CytoSoftMedical Packaging CorporationHHT2026-02-18
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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
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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