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
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00609576381119Puritan®25-806 2PC YELLOW25-806 2PC YELLOW2026-07-27
00609576381133Puritan®25-806 2PC PINK25-806 2PC PINK2026-07-27
00609576381423Puritan®25-806 1PD BT25-806 1PD BT2026-07-27
00609576381676Puritan®25-806 10WCL25-806 10WCL2026-07-27
00609576901799Puritan®25-806 2PC WHITE25-806 2PC WHITE2026-07-27
30609576381196Puritan®25-806 2PR TT25-806 2PR TT2026-07-27
50609576700274Puritan®711-FS711-FS2026-07-27
00609576010378BD ProbeTec25-44135725-4413572026-07-02
00609576700095Puritan®710 CHERRY710 CHERRY2026-07-20
00609576700101Puritan®710 STRAWBERRY710 STRAWBERRY2026-07-20
00609576700118Puritan®710 GRAPE710 GRAPE2026-07-20
10609576150064Puritan®1506-PFB DM1506-PFB DM2026-07-20
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10609576330657Puritan® PurFlock Ultra®3316-U EMB 79MM RING3316-U EMB 79MM RING2026-07-20
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Primary DI, Brand, Company table
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