FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Lima PSI
DI: E314KNMLM010401
·
Model: KNM-LM01-04-01
·
Materialise NV
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lima PSI
- Primary DI
- E314KNMLM010401
- Version / Model
- KNM-LM01-04-01
- Catalog Number
- KNM-LM01-04-01
- Company Name
- Materialise NV
- Labeler DUNS
- 373139427
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-01
- Public Version
- 4
- Public Version Date
- 2019-11-27
- Public Version Status
- Update
- Public Device Record Key
- 9b9c9309-b98f-4be7-9a00-1833a9d06abb
- Distribution End Date
- 2017-07-21
Device Description
Lima MRI TKA tibia bone model
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OOG | Knee Arthroplasty Implantation System | Orthopedic | 888.3560 | 2 |
| OIY | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | Orthopedic | 888.3560 | 2 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Orthopedic | 888.3565 | 2 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62215 | Custom-made organ/bone anatomy model | A model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier, and may be sterilized prior to use in sterile fields. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E314KNMLM010401 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162273 | 000 |