FDA.reportPublic FDA data

Bar type Torque Wrench

Primary DI
08800041358847
Brand
Bar type Torque Wrench
Company
sewon medix Inc.
Model
STW30B
Catalog number
STW30B
Device description
SEWON MEDIX Bar type Torque Wrench 30N, Round
Published
2019-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800041358847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800041358847088000413588478800041358847

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable device.

Regulatory Flags#

DUNS number
688731065
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800041365098XP-I SLA FixtureAIH2FM3508SAIH2FM3508S2022-02-16
08800041365104XP-I SLA FixtureAIH2FM3510SAIH2FM3510S2022-02-16
08800041365111XP-I SLA FixtureAIH2FM3511SAIH2FM3511S2022-02-16
08800041365128XP-I SLA FixtureAIH2FM3513SAIH2FM3513S2022-02-16
08800041365135XP-I SLA FixtureAIH2FM3515SAIH2FM3515S2022-02-16
08800041365142XP-I SLA FixtureAIH2FR3507SAIH2FR3507S2022-02-16
08800041365159XP-I SLA FixtureAIH2FR3508SAIH2FR3508S2022-02-16
08800041365166XP-I SLA FixtureAIH2FR3510SAIH2FR3510S2022-02-16
08800041365173XP-I SLA FixtureAIH2FR3511SAIH2FR3511S2022-02-16
08800041365180XP-I SLA FixtureAIH2FR3513SAIH2FR3513S2022-02-16
08800041365197XP-I SLA FixtureAIH2FR3515SAIH2FR3515S2022-02-16
08800041365203XP-I SLA FixtureAIH2FR4007SAIH2FR4007S2022-02-16
08800041365210XP-I SLA FixtureAIH2FR4008SAIH2FR4008S2022-02-16
08800041365227XP-I SLA FixtureAIH2FR4010SAIH2FR4010S2022-02-16
08800041365234XP-I SLA FixtureAIH2FR4011SAIH2FR4011S2022-02-16
08800041365241XP-I SLA FixtureAIH2FR4013SAIH2FR4013S2022-02-16
08800041365258XP-I SLA FixtureAIH2FR4015SAIH2FR4015S2022-02-16
08800041365265XP-I SLA FixtureAIH2FR4507SAIH2FR4507S2022-02-16
08800041365272XP-I SLA FixtureAIH2FR4508SAIH2FR4508S2022-02-16
08800041365289XP-I SLA FixtureAIH2FR4510SAIH2FR4510S2022-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09