FDA.reportPublic FDA data

Mighty Mixer Bowl

Primary DI
00840161304094
Brand
Mighty Mixer Bowl
Company
ZIRC DENTAL PRODUCTS, INC.
Model
50Z505-ASTD
Device description
"Mighty Mixer Bowl 36pk Assorted, Disposable, eliminating cleanup time, Fits securely into mixing bowl without slippage, Free-standing for use with or without mixing bowl, Capable for use with electric Alginate mixers 9 x Teal 9 x Neon Blue 9 x Neon Green 9 x Neon Purple"
Published
2022-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161304094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161304094008401613040948401613040940840161304094

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, reusableA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height114Millimeter
Length267Millimeter
Width254Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
064783913
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample Pack50Z953SMPL-US2026-02-19
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00840161311788Pink Petal™ - Saliva Ejector Holder - 3 Count Sample Pack50Z976SMPL-US50Z9762026-02-19
00840161311801Mr. Thirsty® One-Step - High Volume Evacuator - Variety 3 Count Sample P50Z989SMPL-US2026-02-19
00840161301468Steri-Endo Guard - Endo Holder - Hand - White - 1 Count50Z450A50Z450A2026-02-14
00840161301475Steri-Endo Guard - Endo Holder - Hand - Blue - 1 Count50Z450B50Z450B2026-02-14
00840161301482Steri-Endo Guard - Endo Holder - Hand - Green - 1 Count50Z450D50Z450D2026-02-14
00840161301499Steri-Endo Guard - Endo Holder - Hand - Beige - 1 Count50Z450G50Z450G2026-02-14
00840161301505Steri-Endo Guard - Endo Holder - Hand - Gray - 1 Count50Z450I50Z450I2026-02-14
00840161301512Steri-Endo Guard - Endo Holder - Hand - Plum - 1 Count50Z450E50Z450E2026-02-14
00840161301529Steri-Endo Guard - Endo Holder - Hand - Teal - 1 Count50Z450J50Z450J2026-02-14
00840161301536Steri-Endo Guard - Endo Holder - Hand - Red - 1 Count50Z450M50Z450M2026-02-14
00840161301543Steri-Endo Guard - Endo Holder - Hand - Midnight - 1 Count50Z450T50Z450T2026-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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