SurgiCase O-01-0-105000-0011-010

GUDID E314O0101050000011010

Humerus Osteotomy

Materialise NV

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

• Primary Device ID: E314O0101050000011010
• NIH Device Record Key: 1b99dd13-956e-47cd-8db7-32b54794e8a0
• Commercial Distribution Discontinuation: 2017-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SurgiCase
• Version Model Number: O-01-0-105000-0011-010
• Catalog Number: O-01-0-105000-0011-010
• 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: 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	E314O0101050000011010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112389

FDA Product Code

• PBF: Orthopaedic Surgical Planning And Instrument Guides

Sterilization

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

[E314O0101050000011010]

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: 2016-09-24

On-Brand Devices [SurgiCase]

• E314SURGICASECONNECTIP0: SurgiCase Connect (iPad)
• E314SURGICASECONNECT0: SurgiCase Connect
• E314SURGICASECMF0: SurgiCase CMF
• E314UEAMA1000010: Anatomical model, Pediatric
• E314UEAMA0100010: Radius/ulna osteotomy, Pediatric
• E314O02055700000113000: Total Hip Arthroplasty
• E314O0205570000011300: Total Hip Arthroplasty
• E314O01082800000110000: Clavicle Osteotomy
• E314O01030600000110100: Femur Osteotomy
• E314O0103060000011010: Femur Osteotomy
• E314O01030300000110100: Tibia/Fibula Osteotomy
• E314O0103030000011010: Tibia/Fibula Osteotomy
• E314O01020000000110100: 'Hand Osteotomy
• E314O01010500000110100: Humerus Osteotomy
• E314O0101050000011010: Humerus Osteotomy
• E314O01010100000110100: Radius/ulna osteotomy
• E314O0101010000011010: Radius/ulna osteotomy
• E314O00300000000010000: Bone models
• E314H00877000000010000: HeartPrint anatomical model
• E314H0087700000001000: HeartPrint anatomical model
• E314C00390000000110000: Anatomical model
• E314C0039000000011000: Anatomical model