FDA.reportPublic FDA data

Ortho Shop

Primary DI
00810152071533
Brand
Ortho Shop
Company
Orthoshop, LLC
Model
8602-0309
Catalog number
8602-0309
Device description
Orthodontic Elastomeric Chain - 15ft - Long - Aqua
Published
2023-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECIBand, Elastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810152071533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810152071533008101520715338101520715330810152071533

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic inter-bracket elastic chainA non-sterile device intended to be used during orthodontic treatment to function as an archwire/bracket ligature on several adjacent teeth and/or to exert a continuous light force to close the spaces between the teeth. It is also known as a power chain and is in the form of a series of connected loops made of an elastomeric material (e.g., polyurethane, rubber). This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129808388
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810152070000Mini Maxx S 1011-22-553451011-22-553452023-11-24
00810152070017Mini Maxx S 1011-22-5531011-22-5532023-11-24
00810152070024Mini Maxx S 1011-18-553451011-18-553452023-11-24
00810152070031Mini Maxx S 1011-18-5531011-18-5532023-11-24
00810152070048Lucchesi Sub-Slot2011-22-553452011-22-553452023-11-24
00810152070055ICON 3034-22-5533034-22-5532023-11-24
00810152070062ICON 3034-22-553453034-22-553452023-11-24
00810152070079Mini Maxx S 1011-22-111011-22-112023-11-24
00810152070086Mini Maxx S 1011-22-211011-22-212023-11-24
00810152070093Mini Maxx S 1011-22-121011-22-122023-11-24
00810152070109Mini Maxx S 1011-22-221011-22-222023-11-24
00810152070116Mini Maxx S 1011-22-13H1011-22-13H2023-11-24
00810152070123Mini Maxx S 1011-22-23H1011-22-23H2023-11-24
00810152070130Mini Maxx S 1011-22-14H1011-22-14H2023-11-24
00810152070147Mini Maxx S 1011-22-141011-22-142023-11-24
00810152070154Mini Maxx S 1011-22-24H1011-22-24H2023-11-24
00810152070161Mini Maxx S 1011-22-241011-22-242023-11-24
00810152070178Mini Maxx S 1011-22-15H1011-22-15H2023-11-24
00810152070185Mini Maxx S 1011-22-151011-22-152023-11-24
00810152070192Mini Maxx S 1011-22-25H1011-22-25H2023-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611213051ORTHOMETRIC MODULAR LIGATURE 22 TIES - LIME GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213105ORTHOMETRIC MODULAR LIGATURE 22 TIES - NEON YELLOWORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213754ORTHOMETRIC MODULAR LIGATURE 22 TIES - GREEN ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611213891ORTHOMETRIC MODULAR LIGATURE 22 TIES - EMERALD GREENORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215031ORTHOMETRIC ELASTIC STICK LIGATURE - METALIC NAVYORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215048ORTHOMETRIC ELASTIC STICK LIGATURE - ROYAL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215055ORTHOMETRIC ELASTIC STICK LIGATURE - METALIC BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215062ORTHOMETRIC ELASTIC STICK LIGATURE - OCEAN BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611215079ORTHOMETRIC ELASTIC STICK LIGATURE - TURQUOISEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-12-18
07908611210333ICERAM-P MBT 0.022 KIT + 1 PAIR OF ESTHETIC ARCHWIRES + 1 PEARL BLUE MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611211163PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611211170PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULARORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-07
07908611210319KIT ICERAM-P ROTH 0.022 + 1 PAIR OF ESTHETIC ARCHWIRE + 1 MODULAR PEARL BLUEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-03
07908470704738KIT ADVANCED METAL BRACKETS ROTH 0.022 10 SETS + ARCHES + ELASTICORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
07908470704776KIT ADVANCED METAL BRACKETS MBT 0.022 10 SETS + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
07908470704912KIT ADVANCED METAL BRACKETS ROTH 0.022 01 SET + ARCHES + ELASTICSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECI2025-04-02
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10190886033876NAG & H Wire Company, Inc.ECI2025-03-26
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10190886101377NAG & H Wire Company, Inc.ECI2025-03-26
10190886101384NAG & H Wire Company, Inc.ECI2025-03-26
10190886101391NAG & H Wire Company, Inc.ECI2025-03-26
10190886101407NAG & H Wire Company, Inc.ECI2025-03-26
10190886101414NAG & H Wire Company, Inc.ECI2025-03-26
10190886101421NAG & H Wire Company, Inc.ECI2025-03-26
10190886101438NAG & H Wire Company, Inc.ECI2025-03-26
10190886101445NAG & H Wire Company, Inc.ECI2025-03-26
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10190886101469NAG & H Wire Company, Inc.ECI2025-03-26