FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096401264
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T8144
Catalog number
T8144
Device description
20 Degree Alignment Guide
Published
2020-05-13
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
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096401264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401264008400964012648400964012640840096401264

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle0

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
00840096408690Viant Medical, LLCT15467T154672020-09-03
00840096408706Viant Medical, LLCT15468T154682020-09-03
00840096408713Viant Medical, LLCT15469T154692020-09-03
00840096408720Viant Medical, LLCT15470T154702020-09-03
00840096408737Viant Medical, LLCT15471T154712020-09-03
00840096408744Viant Medical, LLCT15472T154722020-09-03
00840096408751Viant Medical, LLCT15473T154732020-09-03
00840096408768Viant Medical, LLCT15474T154742020-09-03
00840096408775Viant Medical, LLCT15475T154752020-09-03
00840096408782Viant Medical, LLCT15476T154762020-09-03
00840096408799Viant Medical, LLCT15477T154772020-09-03
00840096408805Viant Medical, LLCT15478T154782020-09-03
00840096408812Viant Medical, LLCT15479T154792020-09-03
00840096408829Viant Medical, LLCT15480T154802020-09-03
00840096408836Viant Medical, LLCT15481T154812020-09-03
00840096408843Viant Medical, LLCT15482T154822020-09-03
00840096408850Viant Medical, LLCT15483T154832020-09-03
00840096408867Viant Medical, LLCT15484T154842020-09-03
00840096408874Viant Medical, LLCT15485T154852020-09-03
00840096408881Viant Medical, LLCT15486T154862020-09-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10886982350640VOLTSynthes GmbHFZX2026-09-25
10886982350657VOLTSynthes GmbHFZX2026-09-25
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10886982350671VOLTSynthes GmbHFZX2026-09-25
10886982350688VOLTSynthes GmbHFZX2026-09-25
10886982351098VOLTSynthes GmbHFZX2026-09-25
10886982351104VOLTSynthes GmbHFZX2026-09-25
10886982351111VOLTSynthes GmbHFZX2026-09-25
10886982351128VOLTSynthes GmbHFZX2026-09-25
10886982351135VOLTSynthes GmbHFZX2026-09-25
10886982351142VOLTSynthes GmbHFZX2026-09-25
10886982351692VOLTSynthes GmbHFZX2026-09-25
10886982357182VOLTSynthes GmbHFZX2026-09-25
00190776432164MillenniumAvalign Technologies, Inc.FZX2026-09-22
00810111228527Drill GuideTreace Medical Concepts, Inc.FZX2026-09-21
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22