Lima PSI SHC-LM01-00-01

GUDID E314SHCLM0100010

Lima CT RSA guide and bone model

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit

• Primary Device ID: E314SHCLM0100010
• NIH Device Record Key: 07524bc4-2bc9-4c3d-8394-847a1c822445
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lima PSI
• Version Model Number: SHC-LM01-00-01
• Catalog Number: SHC-LM01-00-01
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E314SHCLM010001 [Previous]
HIBCC	E314SHCLM0100010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153602

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

[E314SHCLM0100010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-07-21

On-Brand Devices [Lima PSI]

• E314SHCLM1000010: Lima CT Full scapula bone model
• E314SHCLM100001: Lima CT Full scapula bone model
• E314SHCLM0202010: Lima CT TSA bone model
• E314SHCLM020201: Lima CT TSA bone model
• E314SHCLM0200010: Lima CT TSA guide and bone model
• E314SHCLM020001: Lima CT TSA guide and bone model
• E314SHCLM0102010: Lima CT RSA bone model
• E314SHCLM010201: Lima CT RSA bone model
• E314SHCLM0100010: Lima CT RSA guide and bone model
• E314SHCLM010001: Lima CT RSA guide and bone model
• E314KNMLM0104010: Lima MRI TKA tibia bone model
• E314KNMLM010401: Lima MRI TKA tibia bone model
• E314KNMLM0103010: Lima MRI TKA femur bone model
• E314KNMLM010301: Lima MRI TKA femur bone model
• E314KNMLM0100010: Lima MRI TKA guides and bone models
• E314KNMLM010001: Lima MRI TKA guides and bone models
• E314SHCLM0201010: Lima CT TSA guide
• E314SHCLM020101: Lima CT TSA guide
• E314SHCLM0101010: Lima CT RSA guide
• E314SHCLM010101: Lima CT RSA guide
• E314KNMLM0200010: Lima MRI TKA guides
• E314KNMLM020001: Lima MRI TKA guides
• E314KNMLM0102010: Lima MRI TKA tibia guide
• E314KNMLM010201: Lima MRI TKA tibia guide
• E314KNMLM0101010: Lima MRI TKA femur guide
• E314KNMLM010101: Lima MRI TKA femur guide