FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096405606
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T17443
Catalog number
T17443
Device description
Acetabular Reamer 73 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
OTC
false
Sterile
false
Single use
false

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
00840096405606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096405606008400964056068400964056060840096405606

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 Diameter73Millimeter

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
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 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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04026575288519MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288533MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06