AccessGUDID - DEVICE: VSP System, VSP Cranial (00816847021289)

GUDID

Device Identifier (DI) Information

Brand Name: VSP System, VSP Cranial
Version or Model: Implant Template
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: 3D SYSTEMS, INC.

Primary DI Number: 00816847021289
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 anatomy. To be used as pre- and intraoperative reference for the surgeon to visualize patient anatomy. Model may also be used to pre-contour off-the-shelf 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?
58804	Surgical implant template, single-use	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZJ	Driver, Wire, And Bone Drill, Manual
LLZ	System, Image Processing, Radiological
PPT	Cranial Surgical Planning And Instrument Guides

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K120956	000
K133907	000
K151285	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: d8d65a18-2a41-43f1-9b6a-e58ea04fdde0
Public Version Date: August 30, 2023
Public Version Number: 4
DI Record Publish Date: September 12, 2016