Bipolar Head 9050.10.201

GUDID 08033390112314

Trial Head Inserter

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390112314
NIH Device Record Keycb521ae5-a105-4da5-9f31-aab8fe1ab702
Commercial Distribution StatusIn Commercial Distribution
Brand NameBipolar Head
Version Model NumberTrial Head Inserter
Catalog Number9050.10.201
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033390112314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390112314]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-06-17

On-Brand Devices [Bipolar Head]

08033390112314Trial Head Inserter
08033390032506Trial Head Dia.54mm
08033390032490Trial Head Dia.53mm
08033390032476Trial Head Dia.52mm
08033390032469Trial Head Dia.51mm
08033390032452Trial Head Dia.50mm
08033390032445Trial Head Dia.49mm
08033390032438Trial Head Dia.48mm
08033390032414Trial Head Dia.47mm
08033390032407Trial Head Dia.46mm
08033390032391Trial Head Dia.45mm

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