FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401318
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
512779
Catalog number
00-2360-080-00
Device description
Torque Limiting Attachment for 3.5/2.7mm Instruments
Published
2020-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00840096401318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401318008400964013188400964013180840096401318

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

Regulatory Flags#

DUNS number
100512072
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
00840096400045Viant Medical, LLC5111725111722020-09-29
00840096400069Viant Medical, LLCT17651T176512020-09-29
00840096403848Viant Medical, LLC5112725112722020-08-08
00840096403855Viant Medical, LLC5112735112732020-08-08
00840096401011Viant Medical, LLC5109125109122020-05-14
00840096401127Viant Medical, LLCT10491T104912020-05-14
00840096401141Viant Medical, LLCT12230T122302020-05-14
00840096401158Viant Medical, LLCT14174T141742020-05-14
00840096401165Viant Medical, LLCT14331T143312020-05-14
00840096401172Viant Medical, LLCT15752T157522020-05-14
00840096401189Viant Medical, LLCT16611T166112020-05-14
00840096401196Viant Medical, LLCT17703T177032020-05-14
00840096401233Viant Medical, LLCT8044T80442020-05-14
00840096401240Viant Medical, LLCT8088T80882020-05-14
00840096401257Viant Medical, LLCT8143T81432020-05-14
00840096401271Viant Medical, LLCT8177T81772020-05-14
00840096401288Viant Medical, LLCT8468T84682020-05-14
00840096401295Viant Medical, LLCT9316T93162020-05-14
00840096401042Viant Medical, LLCP290200-1206-091-122020-10-23
00840096401059Viant Medical, LLCP290300-1206-091-112020-10-23

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