FDA.report

Tecomet

Primary DI
00841435102811
Brand
Tecomet
Company
TECOMET INC.
Model
PT115012-A
Device description
Torque Limiting, Bi-Directional, Palm Impactor 1/4" Square Quick Lock, Black
Published
2020-10-12
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

Related Records

Product Codes

CodeName
HWAImpactor

Product Code Classifications

CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841435102811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841435102811008414351028118414351028110841435102811

GMDN Terms

TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. 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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
078749695
Device count
1
DM exempt
true
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
true

Other Devices From This Company

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00841435122574Tecomet004803105002026-02-27
00841435124929Tecomet800-08-0182026-02-26
00841435111554TecometTLG132075-J2025-11-14
00841435124295Tecomet004816002012025-09-15
00841435124912TecometAR-9938-112025-09-05
00841435111080Tecomet465722025-08-27
00841435111103Tecomet479312025-08-27
00841435111127Tecomet482422025-08-27
00841435111134Tecomet482442025-08-27
00841435111141Tecomet482452025-08-27
00841435111158Tecomet482462025-08-27
00841435111165Tecomet482542025-08-27
00841435111172Tecomet482482025-08-27
00841435111189Tecomet482592025-08-27
00841435111202Tecomet482692025-08-27
00841435118263Tecomet004819011002025-08-27
00841435118287Tecomet004819014002025-08-27
00841435118317TecometK000-20102025-08-27

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