FDA.report

DELTA CUP ACCESSORIES

Primary DI
08033390041089
Brand
DELTA CUP ACCESSORIES
Company
LIMACORPORATE SPA
Model
Neutral Liner
Catalog number
5885.51.160
Device description
Neutral Liners (UHMWPE X-LIMA + Ti6Al4V) I.D. 32mm - Size LARGE
Published
2015-07-31
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

Product Codes

CodeName
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Product Code Classifications

CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390041089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390041089080333900410898033390041089

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
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
432066322
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
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
false
Sterilization required before use
false

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