Lima PSI KNM-LM01-00-01

GUDID E314KNMLM0100010

Lima MRI TKA guides and bone models

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device IDE314KNMLM0100010
NIH Device Record Keydf8333ee-d1bc-41af-967f-d225c8fe6d85
Commercial Distribution StatusIn Commercial Distribution
Brand NameLima PSI
Version Model NumberKNM-LM01-00-01
Catalog NumberKNM-LM01-00-01
Company DUNS373139427
Company NameMaterialise NV
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
HIBCCE314KNMLM010001 [Previous]
HIBCCE314KNMLM0100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


[E314KNMLM0100010]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2017-07-21

On-Brand Devices [Lima PSI]

E314SHCLM1000010Lima CT Full scapula bone model
E314SHCLM100001Lima CT Full scapula bone model
E314SHCLM0202010Lima CT TSA bone model
E314SHCLM020201Lima CT TSA bone model
E314SHCLM0200010Lima CT TSA guide and bone model
E314SHCLM020001Lima CT TSA guide and bone model
E314SHCLM0102010Lima CT RSA bone model
E314SHCLM010201Lima CT RSA bone model
E314SHCLM0100010Lima CT RSA guide and bone model
E314SHCLM010001Lima CT RSA guide and bone model
E314KNMLM0104010Lima MRI TKA tibia bone model
E314KNMLM010401Lima MRI TKA tibia bone model
E314KNMLM0103010Lima MRI TKA femur bone model
E314KNMLM010301Lima MRI TKA femur bone model
E314KNMLM0100010Lima MRI TKA guides and bone models
E314KNMLM010001Lima MRI TKA guides and bone models
E314SHCLM0201010Lima CT TSA guide
E314SHCLM020101Lima CT TSA guide
E314SHCLM0101010Lima CT RSA guide
E314SHCLM010101Lima CT RSA guide
E314KNMLM0200010Lima MRI TKA guides
E314KNMLM020001Lima MRI TKA guides
E314KNMLM0102010Lima MRI TKA tibia guide
E314KNMLM010201Lima MRI TKA tibia guide
E314KNMLM0101010Lima MRI TKA femur guide
E314KNMLM010101Lima MRI TKA femur guide

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