Logical Cup Liner

GUDID 09348215054175

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner
Primary Device ID09348215054175
NIH Device Record Keyb23f9725-c29e-498b-99e9-70a2ae94705f
Commercial Distribution StatusIn Commercial Distribution
Brand NameLogical Cup Liner
Version Model NumberD111-12-0652
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215054175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

On-Brand Devices [Logical Cup Liner]

09348215054458D111-12-8460
09348215054441D111-12-8456
09348215054434D111-12-8660
09348215054427D111-12-8656
09348215054410D111-12-8652
09348215054403D111-12-8260
09348215054397D111-12-8256
09348215054380D111-12-8252
09348215054373D111-12-8250
09348215054366D111-12-8852
09348215054359D111-12-8850
09348215054342D111-12-8844
09348215054335D111-12-7460
09348215054328D111-12-7456
09348215054311D111-12-7660
09348215054304D111-12-7656
09348215054298D111-12-7652
09348215054281D111-12-7260
09348215054274D111-12-7256
09348215054267D111-12-7252
09348215054250D111-12-7250
09348215054243D111-12-7852
09348215054236D111-12-7850
09348215054229D111-12-7844
09348215054212D111-12-0460
09348215054205D111-12-0456
09348215054199D111-12-0660
09348215054182D111-12-0656
09348215054175D111-12-0652
09348215054168D111-12-0260
09348215054151D111-12-0256
09348215054144D111-12-0252
09348215054137D111-12-0250
09348215054120D111-12-0852
09348215054113D111-12-0850
09348215054106D111-12-0844
09348215053796D111-12-5457
09348215052454D111-12-6460
09348215052447D111-12-6456
09348215052430D111-12-6660
09348215052423D111-12-6656
09348215052416D111-12-6652
09348215052409D111-12-6260
09348215052393D111-12-6256
09348215052386D111-12-6252
09348215052379D111-12-6250
09348215052362D111-12-6852
09348215052355D111-12-6850
09348215052348D111-12-6844
09348215052331D111-12-5460

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