SurgiCase H-00-8-770000-0001-000

GUDID E314H00877000000010000

HeartPrint anatomical model

Materialise NV

Custom-made organ/bone anatomy model

• Primary Device ID: E314H00877000000010000
• NIH Device Record Key: 1f01ba48-3c24-4e85-9ec7-267735655d09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiCase
• Version Model Number: H-00-8-770000-0001-000
• Catalog Number: H-00-8-770000-0001-000
• Company DUNS: 373139427
• Company Name: Materialise NV
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	E314H0087700000001000 [Previous]
HIBCC	E314H00877000000010000 [Primary]

FDA Product Code

• HWT: Template

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-07-21

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