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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
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00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

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Primary DI, Brand, Company table
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