AccessGUDID - DEVICE: TEETHAN (B179THN2)

GUDID

Device Identifier (DI) Information

Brand Name: TEETHAN
Version or Model: 2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BTSEMB1BM
Company Name: BTS SPA

Primary DI Number: B179THN2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 428484518 *Terms of Use

Device Description: Indication for use: To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

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:	No
Combination Product:	Yes
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?
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZM	Device, Muscle Monitoring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161716	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: a0127a34-f916-48d0-a5ba-e331b0b93b91
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2017