Acetabular Instrument Set 9CC0.95.032

GUDID 08033390137126

Cannulated Handle M6 with Flange

LIMACORPORATE SPA

Surgical instrument handle, non-torque-limiting
Primary Device ID08033390137126
NIH Device Record Key7d8449a4-b7bb-4f97-af59-e358b08493eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcetabular Instrument Set
Version Model Number9CC0.95.032
Catalog Number9CC0.95.032
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
GS108033390137126 [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

[08033390137126]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-04
Device Publish Date2020-04-24

On-Brand Devices [Acetabular Instrument Set]

08033390066198Liner Positioner LARGE Dia.40 mm
08033390066181Liner Positioner MEDIUM-LARGE Dia.36 mm
08033390066174Liner Positioner SMALL Dia.32 mm
0803339006457645° Joint for Beater
08033390064569Joint for Ceramic Liner Posititioner
0803339006336445° Joint for Ceramic Liner Posititioner
08033390025744Beater-Positioner-Aligner
08033390137126Cannulated Handle M6 with Flange

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.