FDA.reportPublic FDA data

Salvin Molt Mouth Gag

Primary DI
00841336102316
Brand
Salvin Molt Mouth Gag
Company
SALVIN DENTAL SPECIALTIES, LLC
Model
Molt Gag
Published
2023-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00841336102316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841336102316008413361023168413361023160841336102316

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

Regulatory Flags#

DUNS number
113344790
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841336100480L-797BL-797B2015-10-30
00841336100381LV-493BLV-493B2018-02-22
00841336100473L-1180BL-1180B2015-10-30
00841013124457American Eagle InstrumentsAESSIRC2026-01-02
00841336104877Salvin Dental SpecialtiesGRAFT-SYR-2.8-CUGRAFT-SYR-2.8-CU2025-12-22
00841336104891Salvin Dental SpecialtiesGRAFTSYRINGE-STRGRAFTSYRINGE-STR2025-12-22
00841336104907Salvin Dental SpecialtiesGRAFT-SYR-S-CURVGRAFT-SYR-S-CURV2025-12-22
00841336104914Salvin Dental SpecialtiesGRAFT-SYR-S-STRGRAFT-SYR-S-STR2025-12-22
00841336106000Salvin Dental SpecialtiesGR11/12GR11/122025-12-22
00841336106062Salvin Dental SpecialtiesGRAFT-PACK-SERR-LGRAFT-PACK-SERR-L2025-12-22
00841336106079Salvin Dental SpecialtiesGRAFT-PACK-SERR-SGRAFT-PACK-SERR-S2025-12-22
00841336106239Salvin Dental SpecialtiesMEMB-CONDENSERMEMB-CONDENSER2025-12-22
00841336106499Salvin Dental SpecialtiesPIKOS-PACKERPIKOS-PACKER2025-12-22
00841336106697Salvin Dental SpecialtiesSINUS-DETACHSINUS-DETACH2025-12-22
00841336106802Salvin Dental SpecialtiesSUGARMAN-1S/2SSUGARMAN-1S/2S2025-12-22
00841336106819Salvin Dental SpecialtiesSUGARMAN-3S/4SSUGARMAN-3S/4S2025-12-22
00841336106918Salvin Dental SpecialtiesYG7/8YG7/82025-12-22
00841336108639Salvin Dental SpecialtiesIMPLA-SAFE-EXPLORERIMPLA-SAFE-EXPLORER2025-12-22
00841336108653Salvin Dental SpecialtiesIMPLA-SAFE-SOFT-TI-CURETTEIMPLA-SAFE-SOFT-TI-CURETTE2025-12-22
00841336109421Salvin Dental SpecialtiesH6/H7H6/H72025-12-22

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