AccessGUDID - DEVICE: Synapsys VHIT (08054187380822)

GUDID

Device Identifier (DI) Information

Brand Name: Synapsys VHIT
Version or Model: Synapsys VHIT Plus
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10739
Company Name: INVENTIS SRL

Primary DI Number: 08054187380822
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 338454995 *Terms of Use

Device Description: Video Head Impulse Test device

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:	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?
45584	Dynamic visual acuity testing system	An assembly of devices used to track changes in visual acuity during head movements primarily to quantify visual acuity loss due to vestibular pathology. The assembly typically includes a three-dimensional (3-D) integrating gyrometer (or equivalent) fastened to the patient's head, a connected personal computer used to track the patient's ability to correctly identify an image according to a specified head movement, a mounted monitor for image viewing, and operating system software. The system helps to identify patients most likely to benefit from vestibular rehabilitation exercises.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWN	Nystagmograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: bf9491d3-9ca0-4e25-afea-da648ba461a4
Public Version Date: January 16, 2025
Public Version Number: 1
DI Record Publish Date: January 08, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +39 0498962844
Email: quality@inventis.it

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