FDA.reportPublic FDA data

Tecomet

Primary DI
00841435111257
Brand
Tecomet
Company
TECOMET INC.
Model
01-09-3035
Device description
Torque Limiting Adapter
Published
2026-04-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841435111257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841435111257008414351112578414351112570841435111257

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument torque limiterA small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2629254531julie.davis@tecomet.com

Regulatory Flags#

DUNS number
078749695
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818069012915Tecomet3741062023-07-23
00841435109810TecometSR131000-E2026-05-11
00841435111264TecometDB101119-A2026-05-01
00841435111288TecometDB101120-A2026-05-01
00841435124363TecometTW203060-AH2026-05-01
00818069014315TecometMA101000-A2020-08-21
00818069014476TecometSR632000-A2020-08-21
00818069013196TecometCD1020092020-08-10
00818069013226TecometCD1020122020-08-10
00818069014209TecometCD1020142020-08-10
00818069014483TecometTA1010002020-08-10
00818069014520TecometUT1010012020-08-10
00818069010225TecometCD1020022020-08-09
00818069013110TecometCD1020032020-08-09
00818069013127TecometCD1020042020-08-09
00818069014360TecometRS10205912020-08-07
00818069014377TecometRS10207872020-08-07
00818069014384TecometRS10209842020-08-07
00818069014391TecometRS10211812020-08-07
00818069014407TecometRS10213782020-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652789N/ASTRYKER CORPORATIONHWE2026-03-25
07640187462302Power Tool TL Attachment 2.5mmBonebridge AGHWE2025-10-17
07613327649161T2, PANGEAStryker GmbHHWE2025-09-25
07613327566000T2 ALPHAStryker GmbHHWE2024-03-01
07613327566055T2 ALPHAStryker GmbHHWE2024-03-01
07613327566079T2 ALPHAStryker GmbHHWE2024-03-01
07613327538939Prep PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539332Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539349Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327539448Mill PlusSTRYKER CORPORATIONHWE2023-01-04
07613327542134Bone Mill PlusSTRYKER CORPORATIONHWE2022-12-22
07613327467765EZoutSTRYKER CORPORATIONHWE2021-06-17
07613327467864PrecisionSTRYKER CORPORATIONHWE2021-06-17
07613327467819NASTRYKER CORPORATIONHWE2021-06-15
07613327467826NASTRYKER CORPORATIONHWE2021-06-15
07613327467833NASTRYKER CORPORATIONHWE2021-06-15
07613327467840NASTRYKER CORPORATIONHWE2021-06-15
07613327467857NASTRYKER CORPORATIONHWE2021-06-15
08800038040359Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040366Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040373Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040380Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040397Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040403Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040410Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040427Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040441Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17
08800038040458Brasseler EZXIMEDICOM CO., LTD.HWE2020-06-17