REVISION Hip 9038.10.250

GUDID 08033390046817

Trial Neck Extractor

LIMACORPORATE SPA

Orthopaedic implant inserter/extractor, reusable
Primary Device ID08033390046817
NIH Device Record Key25b2d4d5-0b8d-46cb-9d7f-e149d5f233a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameREVISION Hip
Version Model NumberTrial Neck Extractor
Catalog Number9038.10.250
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
GS108033390046817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


[08033390046817]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-05-12

On-Brand Devices [REVISION Hip]

08033390112642Neck Impactor Extractor
08033390046817Trial Neck Extractor
08033390024174Neck Impactor Extractor

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