FDA.reportPublic FDA data

DCI

Primary DI
00810021435091
Brand
DCI
Company
DCI International, LLC
Model
2434
Catalog number
2434
Device description
Mouth Props, Child
Published
2023-06-26
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
EIFAccessories, Retractor, Dental

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810021435091PrimaryGS10
10810021435098Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435091008100214350918100214350910810021435091
1081002143509810810021435098

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
503-537-2445regulatory@dcionline.com

Regulatory Flags#

DUNS number
032221423
Device count
2
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021435916DCI EdgeCP10002026-07-21
00810230800116DCI Parts343034232026-06-26
00810230800123DCI Parts343034242026-06-26
00810230800130DCI Parts343034252026-06-26
00810230800147DCI Parts343034282026-06-26
00810230800154DCI Parts343034292026-06-26
00810230800161DCI Parts343034362026-06-26
00810230800178DCI Parts343034372026-06-26
00810230800185DCI Parts343034382026-06-26
00810230800192DCI Parts343034392026-06-26
00810230800208DCI Parts343034402026-06-26
00810230800215DCI Parts343034412026-06-26
00810230800222DCI Parts343034432026-06-26
00810230800239DCI Parts343034432026-06-26
00810230800246DCI Parts343034442026-06-26
00810230800253DCI Parts343034452026-06-26
00810230800260DCI Parts343034462026-06-26
00810230800277DCI Parts343034472026-06-26
00810230800284DCI Parts343034522026-06-26
00810230800291DCI Parts343034532026-06-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955RETWIED01Paul BandittTerlain Enterprises, Inc.EIF2026-09-25
00810194403415AiraAIRA, LLCEIF2026-08-26
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08800325901202Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901219Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901233Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901257Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901264Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901271Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901288Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901295Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901301Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901318Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901325Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901332Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901370Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901387Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901394Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901400Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901417Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901424Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901431Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901448Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901455Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901462Perfit OneMLVatech mcis Co., LtdEIF2026-07-20