Primary Device ID | 05420060343186 |
NIH Device Record Key | 13c2f7ca-38e5-42ce-80d9-7d02d14cd23d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Materialise Personalized Solutions |
Version Model Number | O-01-0-100000-0221-010 |
Catalog Number | O-01-0-100000-0221-010 |
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 | false |
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 |
---|---|
GS1 | 05420060343186 [Primary] |
PBF | Orthopaedic Surgical Planning And Instrument Guides |
Steralize Prior To Use | true |
Device Is Sterile | false |
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
[05420060343186]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-07-19 |
Device Publish Date | 2023-07-11 |
05420060343407 | Lower extremity Guide and Model |
05420060343391 | Upper Extremity Guide and Model |
05420060343360 | Acromion Osteotomy Guide and Model |
05420060343346 | Pediatric Radius/Ulna Model |
05420060343322 | Femur Osteotomy Guide and Model |
05420060343315 | Tibia/Fibula Osteotomy Guide and Model |
05420060343308 | Clavicle Osteotomy Guide and Model |
05420060343292 | Hand Osteotomy Guide and Model |
05420060343285 | Humerus Osteotomy Guide and Model |
05420060343278 | Pediatric Radius/Ulna Osteotomy Guide and Model |
05420060343261 | Radius/Ulna Osteotomy Guide and Model |
05420060343254 | Bone Model Lower Extremity |
05420060343247 | Bone Model Upper Extremity |
05420060343230 | Acromion Osteotomy Model |
05420060343223 | Acromion Osteotomy Guide |
05420060343209 | Guide Lower Extremity |
05420060343186 | Guide Upper Extremity |
05420060343148 | Bone Model |
05420060343117 | Femur Osteotomy Model |
05420060343100 | Femur Osteotomy Guide |
05420060343094 | Tibia/Fibula Osteotomy Model |
05420060343087 | Tibia/Fibula Osteotomy Guide |
05420060343070 | Clavicle Osteotomy Model |
05420060343063 | Clavicle Osteotomy Guide |
05420060343056 | Hand Osteotomy Model |
05420060343049 | Hand Osteotomy Guide |
05420060343032 | Humerus Osteotomy Model |
05420060343025 | Humerus Osteotomy Guide |
05420060343018 | Radius/Ulna Osteotomy Model |
05420060343001 | Radius/Ulna Osteotomy Guide |