DEVICE: Lafayette Extendable Goniometer (00855170007027)

Device Identifier (DI) Information

Lafayette Extendable Goniometer
01135
In Commercial Distribution
01135
LAFAYETTE INSTRUMENT COMPANY, INC.
00855170007027
GS1

1
005080650 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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.
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FDA Product Code

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Product Code Product Code Name
KQW Goniometer, Nonpowered
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 40 and 95 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6ab98639-df1e-494c-b833-b84a25a6a735
September 08, 2021
1
August 31, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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Yes
No CLOSE

Customer Contact

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765-423-1505
bbrown@lafayetteinstrument.com
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