FDA UDI In Commercial Distribution 🇺🇸 United States

Lafayette Extendable Goniometer

DI: 00855170007027 · Model: 01135 · LAFAYETTE INSTRUMENT COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Lafayette Extendable Goniometer
Primary DI
00855170007027
Version / Model
01135
Catalog Number
01135
Company Name
LAFAYETTE INSTRUMENT COMPANY, INC.
Labeler DUNS
005080650
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-31
Public Version
1
Public Version Date
2021-09-08
Public Version Status
New
Public Device Record Key
6ab98639-df1e-494c-b833-b84a25a6a735

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

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KQW Goniometer, Nonpowered

GMDN Terms

Code Name
33651 Manual goniometer

Identifiers

Type ID
Primary 00855170007027

Customer Contacts

Phone
765-423-1505

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
40 – 95 Degrees Fahrenheit