AccessGUDID - DEVICE: VSP System (00816847021234)

GUDID

Device Identifier (DI) Information

Brand Name: VSP System
Version or Model: Perfected Maxilla/Mandible 2-Piece Model
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3D SYSTEMS, INC.

Primary DI Number: 00816847021234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085049749 *Terms of Use

Device Description: A three dimensional physical model depicting patient specific modified anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize the surgical plan. Model may also be used to pre-contour implants.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
LLZ	System, Image Processing, Radiological
DZJ	Driver, Wire, And Bone Drill, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120956	000
K133907	000
K192192	000
K210347	000

Device Exempt from Premarket Submission: No 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: 3f4e69ac-c665-4a5f-b22a-8ab8b48d8e9b
Public Version Date: August 20, 2024
Public Version Number: 5
DI Record Publish Date: September 12, 2016