FDA.reportPublic FDA data

DCI

Primary DI
00810021435107
Brand
DCI
Company
DCI International, LLC
Model
2433
Catalog number
2433
Device description
Mouth Props, Small Pedo
Published
2023-06-24
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
00810021435107PrimaryGS10
10810021435104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810021435107008100214351078100214351070810021435107
1081002143510410810021435104

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
06954454000250COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000885COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000892COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000908COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000915COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000922COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000939COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000946COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000953COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454000960COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002001COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002308COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002315COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002803COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002810COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002827COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002834COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454002841COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454004876COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005019COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454005026COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006085COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006214COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006221COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006245COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006252COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454006429COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454011867COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013489COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21
06954454013496COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-21