FDA.report

Viant Medical, LLC

Primary DI
00840096401745
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T4473
Catalog number
T4473
Device description
EZ Clean™ Offset Reamer Handle 30 Degree Z
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840096401745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096401745008400964017458400964017450840096401745

GMDN Terms

TermDefinition
Acetabular orthopaedic reamerAn orthopaedic surgical instrument designed to cut and resurface with precision the acetabulum for the acceptance of the acetabular component of a hip joint prosthesis. The device is designed with a hemispherical shell with an abrasive outer surface as the cutting head that is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy and is available in various sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Angle30degree

Sterilization Methods

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 DIBrandModelCatalogPublished
00840096401332Viant Medical, LLCT11773T117732020-05-27
00840096401349Viant Medical, LLCT12673T126732020-05-27
00840096401356Viant Medical, LLCT13879T138792020-05-27
00840096401363Viant Medical, LLCT17712T177122020-05-27
00840096401387Viant Medical, LLCT2482T24822020-05-27
00840096401400Viant Medical, LLCT5326T53262020-05-27
00840096401417Viant Medical, LLCT16096T160962020-11-06
00840096401424Viant Medical, LLCT11774T117742020-05-27
00840096401431Viant Medical, LLCT12413T124132020-05-27
00840096401448Viant Medical, LLCT2227T22272020-05-27
00840096401455Viant Medical, LLC5140395140392020-05-27
00840096401462Viant Medical, LLCT2401T24012020-05-27
00840096401479Viant Medical, LLCT2947T29472020-05-27
00840096401486Viant Medical, LLCT8458T84582020-05-27
00840096401493Viant Medical, LLCT8059T80592020-05-27
00840096401509Viant Medical, LLCT2394T23942020-05-27
00840096401516Viant Medical, LLCT11775T117752020-05-27
00840096401523Viant Medical, LLCT12228T122282020-05-27
00840096401530Viant Medical, LLCT12283T122832020-05-27
00840096401547Viant Medical, LLCT15514T155142020-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19