Model: TP FACE SCAN KIT FOR TP SUPREME 3D
DI: 60192155951237
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
TP FACE SCAN KIT FOR TP SUPREME 3D (CS 9600)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8f7ea91e-77a4-40e3-bee7-8de2bc0173a3
Distribution Status:
In Commercial Distribution
DUNS Number:
019796106
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
60192155951237
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40898
Name: Head/neck procedure positioner
Definition:
A noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. This is a reusable device.
FDA Product Codes
OAS
X-Ray, Tomography, Computed, Dental