FDA.reportPublic FDA data

Poly Mixing Pads with Foam

Primary DI
00616784447322
Brand
Poly Mixing Pads with Foam
Company
Dynarex Corporation
Model
4473
Device description
"Poly Mixing Pads with Foam Back- (poly 2 side), 3""x3"", Poly-coated, 100 sheets per pad"
Published
2021-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784447339PackageGS16In Commercial Distribution
00616784447322PrimaryGS10
00616784447315Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784447339006167844473396167844473390616784447339
00616784447322006167844473226167844473220616784447322
00616784447315006167844473156167844473150616784447315

GMDN Terms#

Term, Definition table
TermDefinition
Dental material mixing surface, chairside, single-useA pad, tray, well, or palette with wells intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a single-use device.

Regulatory Flags#

DUNS number
008124539
Device count
3
Premarket exempt
true
No natural rubber latex
true

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00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
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