FDA.reportPublic FDA data

MedTorque

Primary DI
00817247023477
Brand
MedTorque
Company
Arch Medical Solutions Corp.
Model
2RS26-C04-C08
Catalog number
2RS26-C04-C08
Device description
AFX STRAIGHT HANDLE, Z/H
Published
2024-11-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817247023477PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817247023477008172470234778172470234770817247023477

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-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, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
12623584370april.schultz@archgp.com

Regulatory Flags#

DUNS number
118770984
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817247020230MedTorque1HJ1-C012025-03-05
00817247023484MedTorque2RT25-C04-C082RT25-C04-C082024-11-08
00817247023491MedTorque2TS5-C04-C082TS5-C04-C082024-11-08
00817247021725MedTorque1FL2-C011FL2-C012024-03-19
00817247020056MedTorque2FT15-C092023-10-17

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Primary DI, Brand, Company table
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