| Primary Device ID | E314SHCLM0201010 |
| NIH Device Record Key | 51f3d157-ae7d-40c7-8b79-2e107dc71a0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lima PSI |
| Version Model Number | SHC-LM02-01-01 |
| Catalog Number | SHC-LM02-01-01 |
| 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 Issuing Agency | Device ID |
|---|---|
| HIBCC | E314SHCLM020101 [Previous] |
| HIBCC | E314SHCLM0201010 [Primary] |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
[E314SHCLM0201010]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-07-21 |
| 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 |