C2 Hip 9045.16.280

GUDID 08033390071673

M8 Stem Beater-Extractor

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390071673
NIH Device Record Key8572a1d3-11fd-439a-b022-7ec4c89170f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameC2 Hip
Version Model Number9045.16.280
Catalog Number9045.16.280
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
GS108033390071673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


[08033390071673]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2018-03-13

On-Brand Devices [C2 Hip]

08033390071673M8 Stem Beater-Extractor
08033390071666C2 Hip - Lateralized Trial Neck
08033390071659C2 Hip - Trial Neck
08033390066594C2 Hip - Broach # 6
08033390066556C2 Hip - Broach # 2
08033390066549C2 Hip - Broach # 1
08033390066532C2 Hip - Broach # 0
08033390066525C2 Hip - Broach # 01
08033390066655C2 Hip - Broach # 12
08033390066648C2 Hip - Broach # 11
08033390066631C2 Hip - Broach # 10
08033390066624C2 Hip - Broach # 9

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