FDA.reportPublic FDA data

KOLPLAST

Primary DI
07898027905353
Brand
KOLPLAST
Company
Kolplast C I
Model
SWAB HASTE REGULAR D2,5 FP EST
Catalog number
10.4109
Published
2023-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898027905353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898027905353078980279053537898027905353

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
903963889
Device count
1
Premarket exempt
true
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
07898027905902KOLPLASTStandard2019-09-13
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576360251Puritan® Dry Transport System Sterile Flocked Collection DevicePuritan Medical ProductsKXG2026-05-29
38053326007027FLOQSwabs®COPAN ITALIA SPAKXG2026-03-20
08809262391039Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391053Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391060Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391077Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391329Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391336Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391343Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391350Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391367Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391374Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391527Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262391534Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262392104Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394030Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394047Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394061Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394078Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394085Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394092Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394115Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394122Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394139Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394146Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394153Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394177Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394191Specimen Collection SwabHLB CO.,LTDKXG2025-10-28
08809262394207Specimen Collection swabHLB CO.,LTDKXG2025-10-28
08809262394214Specimen Collection SwabHLB CO.,LTDKXG2025-10-28