AccessGUDID - DEVICE: SurgiCase (E314O00300000000010000)

GUDID

Device Identifier (DI) Information

Brand Name: SurgiCase
Version or Model: O-00-3-000000-0001-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: O-00-3-000000-0001-000
Company Name: Materialise NV

Primary DI Number: E314O00300000000010000
Issuing Agency: HIBCC
Commercial Distribution End Date: July 11, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 373139427 *Terms of Use

Device Description: Bone models

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	Template

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9af486dc-8df6-4e5a-ae69-91fe3a681f9b
Public Version Date: August 20, 2024
Public Version Number: 5
DI Record Publish Date: July 21, 2017