FDA.reportPublic FDA data

CS2 Acet. Cup Sys. - VitalitE

Primary DI
00840286810470
Brand
CS2 Acet. Cup Sys. - VitalitE
Company
Shalby Advanced Technologies, Inc.
Model
1720-0-2862
Catalog number
1720-0-2862
Device description
Acet. Insert, Rimless, VitalitE, 28mm ID, 62mm
Published
2022-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHPSystem, telethermographic (sole diagnostic screen)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHPSystem, Telethermographic (Sole Diagnostic Screen)Obstetrics/Gynecology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840286810470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840286810470008402868104708402868104700840286810470

GMDN Terms#

Term, Definition table
TermDefinition
Constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(916)355-7100khansen@consensusortho.com

Regulatory Flags#

DUNS number
085976260
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840286860147Tahoe Unicompartmental Knee System3000-0-17013000-0-17012026-07-10
00840286860154Tahoe Unicompartmental Knee System3000-0-17023000-0-17022026-07-10
00840286860161Tahoe Unicompartmental Knee System3000-0-17033000-0-17032026-07-10
00840286860178Tahoe Unicompartmental Knee System3000-0-17043000-0-17042026-07-10
00840286860185Tahoe Unicompartmental Knee System3000-0-17053000-0-17052026-07-10
00840286860192Tahoe Unicompartmental Knee System3000-0-17063000-0-17062026-07-10
00840286860208Tahoe Unicompartmental Knee System3000-0-17073000-0-17072026-07-10
00840286860215Tahoe Unicompartmental Knee System3000-0-17083000-0-17082026-07-10
00840286860239Tahoe Unicompartmental Knee System3000-0-16023000-0-16022026-07-10
00840286860246Tahoe Unicompartmental Knee System3000-0-16033000-0-16032026-07-10
00840286860253Tahoe Unicompartmental Knee System3000-0-16043000-0-16042026-07-10
00840286860260Tahoe Unicompartmental Knee System3000-0-16053000-0-16052026-07-10
00840286860277Tahoe Unicompartmental Knee System3000-0-16063000-0-16062026-07-10
00840286860284Tahoe Unicompartmental Knee System3000-0-16073000-0-16072026-07-10
00840286860291Tahoe Unicompartmental Knee System3000-0-16083000-0-16082026-07-10
00840286860307Tahoe Unicompartmental Knee System3600-0-00003600-0-00002026-07-10
00840286860314Tahoe Unicompartmental Knee System3600-0-00013600-0-00012026-07-10
00840286860321Tahoe Unicompartmental Knee System3600-0-00023600-0-00022026-07-10
00840286860338Tahoe Unicompartmental Knee System3600-0-00033600-0-00032026-07-10
00840286860345Tahoe Unicompartmental Knee System3600-0-00043600-0-00042026-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840286810371CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810388CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810395CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810401CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810418CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810425CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810432CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810449CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810456CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810463CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810487CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810494CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810500CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810517CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810524CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810531CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810548CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810555CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810562CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810579CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810586CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810593CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810609CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810616CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810623CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810630CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810647CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810654CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810661CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24
00840286810678CS2 Acet. Cup Sys. - VitalitEShalby Advanced Technologies, Inc.LHP2022-01-24