Large Bone Caliper

Basic Information

• Brand Name: Large Bone Caliper
• Primary DI: 00855170007034
• Version / Model: 01293
• Catalog Number: 01293
• 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: 2
• Public Version Date: 2023-06-14
• Public Version Status: Update
• Public Device Record Key: afd65fa5-6bfa-4941-9d60-2520beb18dd6

Device Description

The Large Bone Caliper accurately measures distance in cm. It features a fixed arm and a measurement arm that slides along a scale. The scale indicates the distance between the two arms. Calipers are used to measure body characteristics such as abdominal diameter, wrist, elbow and knee widths, muscle mass, shoulder and chest width, etc. The measurements are accurate to 1mm.

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
48167	General-purpose calliper, plastic	A non-sterile, manually-operated, lubricant free, plastic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of reinforced plastic that cannot be steam sterilized. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855170007034	GS1

Customer Contacts

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

Storage Conditions

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