Hand Evaluation Kit J00109

GUDID 00855170007225

The Lafayette Grip or Pinch Dynamometers are hydraulic strength measuring instruments. They are designed for routine assessment of the grip and/or pinch strength of a patient or can also be used in the evaluation of hand trauma or disease. As the patient either grips or pinches the device, a column of hydraulic fluid activates a pressure gauge mounted on the top of the device. The gauge indicates the pinch or grip force in pounds (lbs) or kilogram force (kgf). A peak needle shows the maximum force applied during a single test. The peak needle is manually reset at the end of the test and peak values are recorded manually. The grip dynamometers also feature an adjustable handle that can accommodate five different grip positions. The Stainless Steel Short Finger Goniometer is used for easy range-of-motion measurements of metacarpal, phalangeal, and interphalangeal joints. There are linear inch and centimeter markings on both sides of the protractors, in opposite directions. The protractors measure 0-150° in 5° increments. Stainless steel. Latex free. Clearly marked numbers make measuring easy. Measures 5.75 inches long.

LAFAYETTE INSTRUMENT COMPANY, INC.

Hand dynamometer/pinchmeter, mechanical

• Primary Device ID: 00855170007225
• NIH Device Record Key: 7ae8d90d-209f-4363-8737-70894720f82a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hand Evaluation Kit
• Version Model Number: J00109
• Catalog Number: J00109
• Company DUNS: 005080650
• Company Name: LAFAYETTE INSTRUMENT COMPANY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com
• Phone: 765-423-1505
• Email: bbrown@lafayetteinstrument.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855170007225 [Primary]

FDA Product Code

• HRW: Dynamometer, Nonpowered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-08
• Device Publish Date: 2021-08-31

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