AccessGUDID - DEVICE: SICAT JMT blue (B915015700301)

GUDID

Device Identifier (DI) Information

Brand Name: SICAT JMT blue
Version or Model: 01570030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NA
Company Name: zebris MEDICAL GmbH

Primary DI Number: B915015700301
Issuing Agency: HIBCC
Commercial Distribution End Date: July 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 328971791 *Terms of Use

Device Description: Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories

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
Handling Environment Temperature: between -20 and 70 Degrees Celsius
Handling 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: 02b4d552-9a4c-4e9c-afb6-5a9ce9afe147
Public Version Date: July 14, 2023
Public Version Number: 2
DI Record Publish Date: December 31, 2021