World 10° Hooded Liner Size 36C

GUDID 09348215065348

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner Non-constrained polyethylene acetabular liner
Primary Device ID09348215065348
NIH Device Record Key0ab9cb3c-1c59-405d-832c-38318f6abd86
Commercial Distribution StatusIn Commercial Distribution
Brand NameWorld 10° Hooded Liner Size 36C
Version Model Number111-49-3154
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
GS109348215065348 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-15
Device Publish Date2021-03-07

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