AccessGUDID - DEVICE: Lafayette Extendable Goniometer (00855170007027)

GUDID

Device Identifier (DI) Information

Brand Name: Lafayette Extendable Goniometer
Version or Model: 01135
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01135
Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.

Primary DI Number: 00855170007027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005080650 *Terms of Use

Device Description: The Lafayette Extendable Goniometer is an angle measurement device used for accurate, versatile, reliable and objective assessment of range of motion. The Extendable Goniometer features a dual scale, 1° increments, extendable and retractable arms, magnified reading window, as well as a compact, lightweight, and portable design. Its arms can extend to 28.00 inches to measure large joints and retract to 8.0 inches to measure all but the smallest joints. Unlike standard goniometers that require the examiner to estimate alignment, the length of the extendable arms allows it to lie over anatomical bony landmarks. The dual scale of 0-180° and 180-0° is magnified four times, improving the accuracy of the reading, thus, reducing the chance for error. Its lightweight ABS plastic construction will ensure continued and long lasting use.

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?
33651	Manual goniometer	A non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQW	Goniometer, Nonpowered

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 40 and 95 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ab98639-df1e-494c-b833-b84a25a6a735
Public Version Date: September 08, 2021
Public Version Number: 1
DI Record Publish Date: August 31, 2021