FDA.reportPublic FDA data

KOHDENT

Primary DI
04251436929465
Brand
KOHDENT
Company
Kohdent Roland Kohler Medizintechnik GmbH & Co. KG
Model
8178
Catalog number
8178
Device description
Mouth prop MCKESSON, for adults - by pairs - orange
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
KBNGAG, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KBNGag, MouthEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251436929465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251436929465042514369294654251436929465

GMDN Terms#

Term, Definition table
TermDefinition
Mouth gag, non-adjustableA mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. 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
G149TBSB71210TBS BASICSACME ENTERPRISE.KBN2026-05-22
G149TBSB71220TBS BASICSACME ENTERPRISE.KBN2026-05-22
G14926002A05TBS DentalACME ENTERPRISE.KBN2026-03-02
G1493807205TBS DentalACME ENTERPRISE.KBN2026-03-02
04250676735287McIvor mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
04250676735300Dehnhardt mouth gagSpiggle & Theis Medizintechnik GmbHKBN2025-09-19
00194613045401MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049294MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049300MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613049317MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613062125MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613088033MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613097981MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098087MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098094MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098117MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613098124MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613114107MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613115432MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119072MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613119089MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120269MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120474MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00194613120863MSI Precision Specialty InstrumentsMed Saver, Inc.KBN2025-08-01
00757770412792Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
00757770431748Bausch + LombBausch & Lomb IncorporatedKBN2025-07-29
D92810605610MOUTH PROP LARGE ADULT-GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
D92810605810MOUTH PROP ENDENTULOUS, GRAY W/ HARGIS/MARTIN ATTACHMENTW.H. Holden, Inc.KBN2025-07-22
00810123209330Adler Instrument CompanyAdler, Inc.KBN2025-05-23
00810123209347Adler Instrument CompanyAdler, Inc.KBN2025-05-23