AccessGUDID - DEVICE: ROMI Dual Inclinometer System (00855170007416)

GUDID

Device Identifier (DI) Information

Brand Name: ROMI Dual Inclinometer System
Version or Model: ACU100-DUAL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ACU100-DUAL
Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.

Primary DI Number: 00855170007416
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005080650 *Terms of Use

Device Description: Pair of Lafayette Range of Motion Inclinometers designed for quick wireless connection when taking dual inclinometer measurements. The Lafayette Range of Motion Inclinometer is capable of taking measurements in three different planes. It can record maximal range of motion movements in flexion/extension, rotation, or front to back. An easy-to-read LCD screen displays the real-time angle along with up to six previously recorded measurements.

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
Storage Environment Temperature: between 50 and 95 Degrees Fahrenheit
Handling Environment Temperature: between 50 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 15f98a0f-6260-4e85-9b06-f82f67f3cf3e
Public Version Date: February 19, 2024
Public Version Number: 1
DI Record Publish Date: February 09, 2024