FDA.reportPublic FDA data

Implant Organizer

Primary DI
00840161304063
Brand
Implant Organizer
Company
ZIRC DENTAL PRODUCTS, INC.
Model
20Z490B
Device description
Implant Organizer
Published
2022-09-28
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
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840161304063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840161304063008401613040638401613040630840161304063

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
Height16Millimeter
Length117Millimeter
Width175Millimeter

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
Primary DIBrandModelCatalogPublished
00840161311511Crystal HD® Mouth Mirrors50Z364SMPL-US2026-02-19
00840161311535Crystal HD® Mouth Mirrors50Z384SMPL-US2026-02-19
00840161311559Midmark - Magnetic Bur Block - 14-Hole - Neon Blue - 1 Count50Z403N-MID2026-02-19
00840161302144Patterson Dental - Steri-Endo Guard, Endo Assist - Replacement Foam for Steri-En50Z451-PAT2026-02-19
00840161311689Insti-Dam® - Latex-Free Rubber Dam - Relaxed Fit - 1 Count Sample Pack50Z457SMPL-US2026-02-19
00840161311702Insti-Dam® - Latex-Free Rubber Dam - 1 Count Sample Pack50Z459SMPL-US2026-02-19
00840161311733Lingua-Fix® - Low-Volume Evacuator - 1 Count Sample Pack50Z953SMPL-US2026-02-19
00840161311740Airway Armor® - Throat Guard - 3 Count Sample Pack50Z960SMPL-US2026-02-19
00840161311764SE Cushion - Saliva Ejector Cushion - 5 Count Sample Pack50Z970SMPL-US2026-02-19
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438394002685Activa InstrumentBioretec OyMDM2026-03-23
06438394002692Activa InstrumentBioretec OyMDM2026-03-23
06438394020382Activa InstrumentBioretec OyMDM2026-03-23
06438394010956Activa InstrumentBioretec OyMDM2026-03-23
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00888867529793Arthrex®ARTHREX, INC.MDM2026-03-16
00888867529823Arthrex®ARTHREX, INC.MDM2026-03-16
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