FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401240
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T8088
Catalog number
T8088
Device description
Offset Cup Impactor
Published
2020-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096401240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401240008400964012408400964012400840096401240

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant impactor, reusableA non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
100512072
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096403671Viant Medical, LLCT5337T53372020-08-12
00840096403688Viant Medical, LLCT5338T53382020-08-12
00840096404074Viant Medical, LLCT5339T53392020-08-12
00840096404081Viant Medical, LLCT5340T53402020-08-12
00840096404098Viant Medical, LLCT5341T53412020-08-12
00840096404104Viant Medical, LLCT5342T53422020-08-12
00840096401356Viant Medical, LLCT13879T138792020-05-27
00840096401363Viant Medical, LLCT17712T177122020-05-27
00840096401431Viant Medical, LLCT12413T124132020-05-27
00840096401455Viant Medical, LLC5140395140392020-05-27
00840096401462Viant Medical, LLCT2401T24012020-05-27
00840096401493Viant Medical, LLCT8059T80592020-05-27
00840096401523Viant Medical, LLCT12228T122282020-05-27
00840096401530Viant Medical, LLCT12283T122832020-05-27
00840096401578Viant Medical, LLCT9152T91522020-05-27
00840096410334Viant Medical, LLCT10195T101952021-06-16
00840096410341Viant Medical, LLCT10196T101962021-06-16
00840096410358Viant Medical, LLCT10197T101972021-06-16
00840096410365Viant Medical, LLCT10198T101982021-06-16
00840096410372Viant Medical, LLCT10199T101992021-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411541MillenniumAvalign Technologies, Inc.HWA2026-08-07
03701089527934AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527941AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089527958AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089528450AMPLITUDEAMPLITUDE SASHWA2026-07-29
03701089547512AMPLITUDEAMPLITUDE SASHWA2026-07-29
18257200103188ALLOGRAFT - CORTICAL,CONSTRUX - MINI PEEK VBROrthofix US LLCHWA2026-07-17
18257200103881ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
18257200103898ALLOQUENT - ALIFOrthofix US LLCHWA2026-07-17
00822409135721N/AOrtho Development CorporationHWA2026-07-16
07630055307781Positioning handle - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307798Positioning handle - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
07630055307804Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2026-07-16
07630055307811Offset Cup Impactor - M10x1.5 interfaceIncipio Devices SAHWA2026-07-16
00840286860406Tahoe Unicompartmental Knee SystemShalby Advanced Technologies, Inc.HWA2026-07-09
00885556925690NASmith & Nephew, Inc.HWA2026-06-04
08809885739751PYXIS 3D Titanium Cervical Cage, CloseGS Medical Co., Ltd.HWA2026-01-28
10603295543718ATTUNEDEPUY (IRELAND)HWA2025-10-31
10603295543725ATTUNEDEPUY (IRELAND)HWA2025-10-31
00841732162709GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
00841732162716GENERIC Surgical InstrumentsCTL Medical CorporationHWA2023-09-27
07613327538601INSTRUMENTHowmedica Osteonics Corp.HWA2023-06-30
10603295549581INHANCEDEPUY (IRELAND)HWA2023-02-28
00885556865491Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWA2023-01-19
00885556865507Universal2 Total Wrist Implant SystemSmith & Nephew, Inc.HWA2023-01-19
10603295539346INHANCEDEPUY (IRELAND)HWA2021-08-30
00840096403848Viant Medical, LLCVIANT MEDICALHWA2020-08-08
00840096401172Viant Medical, LLCVIANT MEDICALHWA2020-05-14
00840096401196Viant Medical, LLCVIANT MEDICALHWA2020-05-14
07630055302458Offset Cup Impactor - M8x1 interfaceIncipio Devices SAHWA2020-04-23