Identity
- Trade Name
- Lafayette Extendable Goniometer FDA UDI
- Generic Name
- Manual goniometer FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 01135 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 01135 FDA UDI
- Primary DI / UDI-DI
- 00855170007027 FDA UDI
- FDA Product Code
- KQW FDA UDI
- GMDN Term
- Manual goniometer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Manual goniometer
Lafayette Extendable Goniometer by Lafayette Instrument Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lafayette Instrument Company
Sources (1)
- FDA UDI 6ab98639-df1e-494c-b833-b84a25a6a735 36 fields · synced Jun 8, 2026