FDA.reportPublic FDA data

KOLPLAST

Primary DI
07898027903601
Brand
KOLPLAST
Company
Kolplast C I
Model
Wireless
Device description
Wireless LED light source for vaginal speculum. Provides illumination during pelvic examination and other gynecological procedures.
Published
2019-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898027903601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898027903601078980279036017898027903601

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose light sourceA mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
903963889
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing 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
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

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Primary DI, Brand, Company table
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03700712434526Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712435851Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436063Maquet PowerLED IIMAQUET SASFTD2025-09-03
03700712436087Maquet PowerLED IIMAQUET SASFTD2025-09-03
00850036790020AliteRevelle Aesthetics, Inc.FTD2025-09-01
00816744027230Myriad-LXNICO CORPORATIONFTD2025-08-11
00860013851576Nova 3QED, INC.FTD2025-05-22
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00860013851514Nova 300QED, INC.FTD2025-05-21
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08800053093941S300 SeriesDENTIS CO. ,LTDFTD2025-02-19
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