FDA.reportPublic FDA data

KOLPLAST

Primary DI
07898027905902
Brand
KOLPLAST
Company
Kolplast C I
Model
Standard
Device description
"""Cervical Sample Collection Kit, intended for collection of cytological specimens from the ectocervix andthe endocervix."""
Published
2019-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
K153128000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153128000Kolplast Cervical Sample Collection KitKolplast CI SA2017-01-13HHT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898027905902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898027905902078980279059027898027905902

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+551149610972daniela.feracin@kolplast.com.br

Regulatory Flags#

DUNS number
903963889
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898027900792CELLPRESERV KOLPLASTFILTRO GIN CELLPRESERV10.13472023-11-29
07898027901355KOLPLASTRETOSIGMOIDOSCOPIO10.13822023-11-29
07898027902130VAGISPEC KOLPLASTESPEC VAG VAGISPEC G LUB E9007009232023-11-29
07898027902154VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO10.13292023-11-29
07898027902161VAGISPEC KOLPLASTESPEC VAG KOLPLAST G LONGO EST10.13302023-11-29
07898027903038VAGISPEC KOLPLASTESPECULO VAG KOLPLAST VIRGEM EKPV2023-11-29
07898027903311KOLPLASTRETOSIGMOIDOSCOPIORETO2023-11-29
07898027903656VAGISPEC KOLPLASTESPEC VAG VAGISPEC P NLUB E9001009212023-11-29
07898027903663VAGISPEC KOLPLASTESPEC VAG VAGISPEC P E LUB9001009232023-11-29
07898027903687VAGISPEC KOLPLASTESPEC VAG VAGISPEC G E NLUB9007009212023-11-29
07898027904110VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M E9054009212023-11-29
07898027904127VAGISPEC KOLPLASTESPEC VAG VAGISPEC M E LUB9054009232023-11-29
07898027905353KOLPLASTSWAB HASTE REGULAR D2,5 FP EST10.41092023-11-29
07898027905490CELLPRESERV KOLPLASTCELLPRESERV GLASS SLIDE4001010982023-11-29
07898027905988VAGISPEC KOLPLASTESPECULO VAG KOLPLAST P NE9001002102023-11-29
07898027906015VAGISPEC KOLPLASTESPECULO VAG KOLPLAST M NE9054002102023-11-29
07898027906312VAGISPEC KOLPLASTESPECULO VAG KOLPLAST G NE9007002102023-11-29
07898027907074VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE10.10382023-11-29
07898027907159VAGISPEC KOLPLASTESPEC VAG KOLP M KOLPLUX NE 2510.12022023-11-29
07898027907166VAGISPEC KOLPLASTESPEC VAG KOLP G KOLPLUX NE10.13922023-11-29

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Primary DI, Brand, Company table
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07898027908460KOLPLASTKolplast C IHHT2023-11-29
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