FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401196
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T17703
Catalog number
T17703
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
00840096401196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401196008400964011968400964011960840096401196

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
00840096401318Viant Medical, LLC51277900-2360-080-002020-10-23
00840096401325Viant Medical, LLC51289600-2360-080-052020-10-23
00840096403787Viant Medical, LLC32-42299132-4229912020-10-23
00840096410051Viant Medical, LLCT394300-7803-095-432020-10-23
00840096410068Viant Medical, LLCT394400-7803-095-442020-10-23
00840096410075Viant Medical, LLCT394500-7803-095-452020-10-23
00840096410082Viant Medical, LLCT394600-7803-095-462020-10-23
00840096410099Viant Medical, LLCT394700-7803-095-472020-10-23
00840096410105Viant Medical, LLCT394800-7803-095-482020-10-23
00840096410112Viant Medical, LLCT394900-7803-095-492020-10-23
00840096410129Viant Medical, LLCT395000-7803-095-502020-10-23
00840096410136Viant Medical, LLCT395100-7803-095-512020-10-23
00840096410143Viant Medical, LLCT395200-7803-095-522020-10-23
00840096410150Viant Medical, LLCT395300-7803-095-532020-10-23
00840096410167Viant Medical, LLCT395400-7803-095-542020-10-23
00840096410174Viant Medical, LLCT395500-7803-095-552020-10-23
00840096410181Viant Medical, LLCT395600-7803-095-562020-10-23
00840096410198Viant Medical, LLCT395700-7803-095-572020-10-23
00840096410204Viant Medical, LLCT395800-7803-095-582020-10-23
00840096410211Viant Medical, LLCT395900-7803-095-592020-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434694MillenniumAvalign Technologies, Inc.HWA2026-10-12
00889795151735APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151742APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00889795151759APEX 3D Total Ankle Replacement SystemParagon 28, Inc.HWA2026-10-12
00190776433789MillenniumAvalign Technologies, Inc.HWA2026-10-08
09421028119184Enztec Partial Knee Femoral Impactor - Angled ArmENZTEC LIMITEDHWA2026-10-07
09421028119191Enztec Partial Knee Femoral Impactor with Slap Hammer - Angled ArmENZTEC LIMITEDHWA2026-10-07
00190446982623DJO SURGICALEncore Medical, L.P.HWA2026-09-30
07640187918816Ortho Development Offset Cup Impactor, 5/16-24 UNF x 3.94MPS Micro Precision Systems AGHWA2026-09-27
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