Lafayette Skinfold Caliper

Basic Information

• Brand Name: Lafayette Skinfold Caliper
• Primary DI: 00855170007010
• Version / Model: 01128
• Catalog Number: 01128
• 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: de89378e-82a8-4df3-85c3-d61ac1ac5eed

Device Description

The Lafayette Skinfold Caliper is an easy to use device for objective assessment of body fat composition. The device features a 0-100mm scale that allows an accurate assessment of a larger portion of the population than other calipers. The spring-loaded arms and pivoting tips adjust automatically for parallel measurement of skinfolds, and the circular tips provide comfort to the patient. The tension spring provides constant pressure over the entire operating range, meeting the pressure requirements of 10g/mm2. The caliper is lightweight, durable, and never needs calibration.

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	Medical Specialty	Regulation #	Device Class
KTZ	Caliper	Orthopedic	888.4150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34890	Skinfold calliper, manual	A hand-held manual instrument designed to assess body fat in subcutaneous adipose tissue by measuring, using mechanical means, the thickness of folds of skin gathered at various areas of the body (typically that on the posterior aspect of the upper arm or on the thighs, back, or over the lower ribs of the chest). It is typically made of metal and/or plastic and is available in various shapes; it includes moveable arms/jaws, typically spring-loaded for even pressure, for application to the skinfolds and has a graduated scale for skinfold-thickness indication. It may include an auxiliary graduated scale to facilitate fine adjustment and increase measurement accuracy (i.e., vernier callipers).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855170007010	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 40 – 95 Degrees Fahrenheit