FDA.reportPublic FDA data

Logical Cup High Wall Liner Vit-E

Primary DI
09348215133535
Brand
Logical Cup High Wall Liner Vit-E
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
111-12-1252E
Published
2024-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215133535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215133535093482151335359348215133535

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
751993028
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215039295Liner Impactor112-152-0022018-10-09
09348215039301Liner Impactor112-152-3342018-10-09
09348215039318Liner Impactor112-152-1212018-10-09
09348215039325Liner Impactor112-152-0032018-10-09
09348215039332Ceramic Liner Inserter Impactor Head112-152-2102018-10-09
09348215039349Ceramic Liner Inserter Impactor Head112-152-2112018-10-09
09348215039356Ceramic Liner Inserter Impactor Head112-152-2122018-10-09
09348215039363Ceramic Liner Inserter Impactor Head112-152-2132018-10-09
09348215039387Ceramic Liner Impact Adaptor112-152-3052018-10-09
09348215039615Quick Release Head Impactor112-212-0172018-10-09
09348215039837Quick Release Stem Impactor112-212-0062018-10-09
09348215040758Head Impactor112-28-00112018-10-09
09348215040796Stem Impactor112-28-00292018-10-09
09348215040826Monoblock Head Impactor112-28-00382018-10-09
09348215040888Mjolnir112-28-00602018-10-12
09348215041250Femoral Impactor122-15-04642018-10-09
09348215041779Tibial Impactor122-15-04622018-10-09
09348215137427Swivel Stem Impactor112-32-03132025-10-10
09348215137434Swivel Stem Impactor - Long112-32-0314 2025-10-10
09348215152673Proximal Reamer Ø12111-552-4222025-09-16

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Primary DI, Brand, Company table
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