FDA.reportPublic FDA data

6.5" Cytology Brush

Primary DI
50813360023023
Brand
6.5" Cytology Brush
Company
TEAM TECHNOLOGIES, INC.
Model
1
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10813360023025PackageGS1100In Commercial Distribution
20813360023022PackageGS11000In Commercial Distribution
30813360023029PackageGS13000In Commercial Distribution
40813360023026PackageGS16000In Commercial Distribution
50813360023023PackageGS13000In Commercial Distribution
00813360023028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081336002302510813360023025
2081336002302220813360023022
3081336002302930813360023029
4081336002302640813360023026
5081336002302350813360023023
00813360023028008133600230288133600230280813360023028

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
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
false
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
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
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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
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08809157488325C27632B&B Company Co.,Ltd.HHT2023-07-17
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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
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