FDA.reportPublic FDA data

CS2 Acet. Cup Sys. - VitalitE

Primary DI
00844588018763
Brand
CS2 Acet. Cup Sys. - VitalitE
Company
CONSENSUS ORTHOPEDICS, INC.
Model
1107-0-2244
Catalog number
1107-0-2244
Device description
Acet. Insert, VitalitE
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OQGHip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00844588018763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00844588018763008445880187638445880187630844588018763

GMDN Terms

TermDefinition
Non-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 does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes

TypeValueUnit
Outer Diameter22Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(916)355-7100zjohnson@consensusortho.com

Regulatory Flags

DUNS number
824905723
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00844588006227Consensus® Knee System2152-0-00062152-0-00062015-10-05
00844588006234Consensus® Knee System2153-0-00012153-0-00012015-10-05
00844588006241Consensus® Knee System2153-0-00022153-0-00022015-10-05
00844588006258Consensus® Knee System2153-0-00032153-0-00032015-10-05
00844588006265Consensus® Knee System2153-0-00042153-0-00042015-10-05
00844588006272Consensus® Knee System2153-0-00052153-0-00052015-10-05
00844588006289Consensus® Knee System2153-0-00062153-0-00062015-10-05
00844588006296Consensus® Knee System2154-0-00012154-0-00012015-10-05

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