FDA.reportPublic FDA data

3M™ Unitek™

Primary DI
00652221002266
Brand
3M™ Unitek™
Company
3m do Brasil Ltda.
Model
001-381
Catalog number
001-381
Device description
Unitek(TM) Milled Twin Extra-Wide Convertible U6/L6 0T/0Off .022 5/Pk
Published
2018-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00652221002266PrimaryGS10
80652221002262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00652221002266006522210022666522210022660652221002266
8065222100226280652221002262

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)423-45883Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
901611820
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
006522210063563M™ Unitek™017-379017-3792018-09-24
006522210063633M™ Unitek™017-380017-3802018-09-24
006522210020203M™ Unitek™001-309001-3092018-09-24
006522210020373M™ Unitek™001-310001-3102018-09-24
006522210020513M™ Unitek™001-327001-3272018-09-24
006522210020683M™ Unitek™001-329001-3292018-09-24
006522210020823M™ Unitek™001-333001-3332018-09-24
006522210020993M™ Unitek™001-334001-3342018-09-24
006522210021053M™ Unitek™001-337001-3372018-09-24
006522210021433M™ Unitek™001-361001-3612018-09-24
006522210021983M™ Unitek™001-374001-3742018-09-24
006522210022043M™ Unitek™001-375001-3752018-09-24
006522210022113M™ Unitek™001-376001-3762018-09-24
006522210022283M™ Unitek™001-377001-3772018-09-24
006522210022423M™ Unitek™001-379001-3792018-09-24
006522210022593M™ Unitek™001-380001-3802018-09-24
006522210022973M™ Unitek™001-523001-5232018-09-24
006522210023273M™ Unitek™001-533001-5332018-09-24
006522210023343M™ Unitek™001-534001-5342018-09-24
006522210023583M™ Unitek™001-617001-6172018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611212702BONDING TUBE PREMIUM ROTH 0.018 - U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213556BONDING TUBE PREMIUM ROTH 0.018 - U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213587BONDING TUBE PREMIUM ROTH 0.018 - L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611213839BONDING TUBE PREMIUM ROTH 0.018 - L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-01-12
07908611204264KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
07908611204271KIT ADVANCED METAL BRACKETS MBT 0.022 01 SET + ARCHES + 4 TUBESORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2025-04-02
10190886052952AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052969AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052976AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052983AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886052990AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053003AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053010AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053027AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053034AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053041AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053058AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053065AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053072AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053089AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053096AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053102AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053119AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053126AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053133AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053140AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053157AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053164AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053171AGILITYG & H Wire Company, Inc.DZD2025-03-27
10190886053188AGILITYG & H Wire Company, Inc.DZD2025-03-27