AccessGUDID - DEVICE: Tizian JMA Optic USB (B915015700231)

GUDID

Device Identifier (DI) Information

Brand Name: Tizian JMA Optic USB
Version or Model: 01570023
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: zebris MEDICAL GmbH

Primary DI Number: B915015700231
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328971791 *Terms of Use

Device Description: Opto-Electronic System including Face-Bow for monitoring and tracking of lower jaw movements and accessories, USB-Version

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35700	Facebow	A caliper-like dynamic dental instrument intended for use in a dental diagnostic procedure to record the relative position of the mandible to the temporomandibular joints (TMJs) and/or to record the spatial relationship between the maxilla and mandible. This determination is intended for use in placing models of the upper and lower jaws into an articulator and/or in assessing a range of movements in the TMJs. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions

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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e0df59b-1db4-46df-9bef-520031aa25a3
Public Version Date: July 28, 2023
Public Version Number: 1
DI Record Publish Date: July 20, 2023