ProPlan CMF SD900.010

GUDID 05420060350108

Patient Specific Instrument and Planning Kit, Cranial Vault Reconstruction with Model

Materialise NV

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

• Primary Device ID: 05420060350108
• NIH Device Record Key: c6a4cde5-660a-4887-937b-a3ba6847d183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProPlan CMF
• Version Model Number: SD900.010
• Catalog Number: SD900.010
• 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: false
• 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
GS1	05420060350108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111558

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[05420060350108]

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: 2016-09-13

On-Brand Devices [ProPlan CMF]

• 05420060355097: Patient Specific Splint and Planning Kit, Orthognathic Kit, one Splint
• 05420060355080: Patient Specific Splint and Planning Kit, Orthognathic Kit, two Splints
• 05420060355066: Patient Specific Splint, Orthognathic
• 05420060355059: Patient Specific Splint, Orthognathic, Intermediate
• 05420060353857: Anatomical Model for PSI Verification, Skull Only
• 05420060353840: Anatomical Model for PSI Verification, Implant Only
• 05420060353833: Anatomical Model for PSI Verification/MultiPiece-White
• 05420060353826: Anatomical Model for PSI Verification/2 Piece-White
• 05420060353819: Anatomical Model for PSI Verification/1 Piece-White
• 05420060353703: Anatomical Model, Child, Graft Site, White
• 05420060353697: Anatomical Model, Child, Skull, White
• 05420060353680: Anatomical Model, Child, Max - Cranium, White
• 05420060353673: Anatomical Model, Child, Max - Orbit, White
• 05420060353666: Anatomical Model, Child, Mand - Orbit, White
• 05420060353659: Anatomical Model, Child, Mand - Max, White
• 05420060353642: Anatomical Model, Child, Cranial Cap, White
• 05420060353635: Anatomical Model, Child, Orbit, White
• 05420060353628: Anatomical Model, Child, Maxilla, White
• 05420060353611: Anatomical Model, Child, Mandible, White
• 05420060353390: Planned Model, Skull, White
• 05420060353383: Planned Model, Maxilla - Cranium, White
• 05420060353376: Planned Model, Maxilla - Orbit, White
• 05420060353369: Planned Model, Mandible - Orbit, White
• 05420060353314: Planned Model, Mandible, White
• 05420060353123: Anatomical Model, Graft Site, White
• 05420060353093: Anatomical Model, Skull, White
• 05420060353086: Anatomical Model, Maxilla - Cranium, White
• 05420060353079: Anatomical Model, Maxilla - Orbit, White
• 05420060353062: Anatomical Model, Mandible - Orbit, White
• 05420060353055: Anatomical Model, Mandible - Maxilla, White
• 05420060353048: Anatomical Model, Cranial Cap, White
• 05420060353031: Anatomical Model, Orbit, White
• 05420060353024: Anatomical Model, Maxilla, White
• 05420060353017: Anatomical Model, Mandible, White
• 05420060352713: Anatomical Model, Teeth, Clear
• 05420060352706: Anatomical Model, Child, Graft Site, Clear
• 05420060352690: Anatomical Model, Child, Skull, Clear
• 05420060352683: Anatomical Model, Child, Maxilla/Cranium, Clear
• 05420060352676: Anatomical Model, Child, Maxilla - Orbit, Clear
• 05420060352669: Anatomical Model, Child, Mandible - Orbit, Clear
• 05420060352652: Anatomical Model, Child, Mandible/Maxilla, Clear
• 05420060352645: Anatomical Model, Child, Cranial Cap, Clear
• 05420060352638: Anatomical Model, Child, Orbit, Clear
• 05420060352621: Anatomical Model, Child, Maxilla, Clear
• 05420060352614: Anatomical Model, Child, Mandible, Clear
• 05420060352393: Planned Model, Skull, Clear
• 05420060352386: Planned Model, Maxilla - Cranium, Clear
• 05420060352379: Planned Model, Maxilla - Orbit, Clear
• 05420060352362: Planned Model, Mandible - Orbit, Clear
• 05420060352317: Planned Model, Mandible, Clear