FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096404500
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T14653
Catalog number
T14653
Device description
Acetabular Reamer 53 mm
Published
2020-08-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096404500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096404500008400964045008400964045000840096404500

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Outer Diameter53Millimeter

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03662663136693Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136709Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136723Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
00888867531659Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531666Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531673Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531697Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531703Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531710Arthrex®ARTHREX, INC.HTO2026-03-16
00843575120205Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120212Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120229Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120236Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120243Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120250Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120267Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120274Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00841731134707Hintermann Series VILEX LLCHTO2026-01-16
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04026575288489MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288502MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288519MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288533MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06