FDA.report

Torque Wrench

Primary DI
08800076418226
Brand
Torque Wrench
Company
Truabutment Korea Co.,Ltd
Model
TW40
Published
2026-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800076418226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800076418226088000764182268800076418226

GMDN Terms

TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
694514760
Device count
1
DM exempt
false
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

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