FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436916632
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
5863
Catalog number
5863
Device description
Tissue Retractors Henahan No.1-1
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436916632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436916632042514369166324251436916632

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevatorA hand-held manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
324006097
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04251436924224KOHDENT733673362021-09-22
04251436924231KOHDENT733773372021-09-22
04251436924392KOHDENT737073702021-09-22
04251436924408KOHDENT737173712021-09-22
04251436925559KOHDENT751075102021-09-22
04251436928604KOHDENT799279922021-09-22
04251436929113KOHDENT814781472021-09-22
04251436929120KOHDENT814881482021-09-22
04251436932281KOHDENT767076702021-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783007466Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007473Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007534Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007541Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007558Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007565Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007572Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007596Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007602Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007619Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007671Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007756Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008159Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008166Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008173Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008197Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008210Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008227Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008234Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008241Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008258Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00840018674547Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674554Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674561Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674493Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
00840018674509Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
04251436943843KOHLERKohler Medizintechnik GmbHEMS2026-03-12
00840018674295Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11