FDA.reportPublic FDA data

KOHLER

Primary DI
04251436943836
Brand
KOHLER
Company
Kohler Medizintechnik GmbH
Model
8401-N
Catalog number
8401-N
Device description
Retractor, MINNESOTA acc. to Dr. Nasseh with 2,0 mm protrusion, 14 cm
Published
2026-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436943836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436943836042514369438364251436943836

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497771649990info@kohler-dental.de

Regulatory Flags#

DUNS number
344386737
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251436919084Kohler6414-CC2026-04-23
04251436943850Kohler83142026-04-23
04251436909030KOHLER451645162026-03-12
04251436934155KOHLER451645162026-03-12
04251436931086KOHLER955795572026-03-12
04251436943805KOHLER842884282026-03-12
04251436943812KOHLER8461-CC8461-CC2026-03-12
04251436943843KOHLER330833082026-03-12
04251436907746KOHDENT430643062021-08-30
04251436943492KOHDENT670067002023-11-28
04251436915819KOHDENT573957392021-09-22
04251436915826KOHDENT574057402021-09-22
04251436915833KOHDENT574157412021-09-22
04251436918094KOHDENT616361632021-09-22
04251436918100KOHDENT616661662021-09-22
04251436918179KOHDENT620962092021-09-22
04251436918186KOHDENT621062102021-09-22
04251436918834KOHDENT635863582021-09-22
04251436921209KOHDENT679267922021-09-22
04251436924217KOHDENT733573352021-09-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901233Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901332Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901486Perfit OneMLVatech mcis Co., LtdEIF2026-07-20