AccessGUDID - DEVICE: KINVENT (03770011995554)

GUDID

Device Identifier (DI) Information

Brand Name: KINVENT
Version or Model: Sens V2R01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KINVENT HELLAS

Primary DI Number: 03770011995554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 524664525 *Terms of Use

Device Description: Sens is an inertial sensor to measure the range of motion and to compare the symmetry between the injured limb’s amplitude and the healthy limb.

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):	No
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?
33652	Electronic goniometer/kinesiology sensor	A small electronic device designed to be fastened to a body part (e.g., a patient worn goniometer-, accelerometer-, or gyroscope-sensor), or hand-held by a clinician (e.g., goniometer), to evaluate a patient’s range of motion/movement of individual joints/limbs/spine; it is used in a clinical setting typically before/after a medical/surgical intervention, or to assess degree of physical fitness. Acquired data may be transferred to a computing device/software for recording/display and analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQX	Goniometer, Ac-Powered

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Temperature: between -10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51ce64df-960f-4115-8295-f635b36a997d
Public Version Date: November 30, 2021
Public Version Number: 2
DI Record Publish Date: August 01, 2020