Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810061910121
• Version / Model: ST4-1455
• Catalog Number: ST4-1455
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-22
• Public Version: 1
• Public Version Date: 2020-09-30
• Public Version Status: New
• Public Device Record Key: 192a7d9b-f35e-448c-88fc-ef746ab1b583

Device Description

Titanium Castroviejo Caliper

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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOE	Caliper, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35787	Ophthalmic calliper	A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810061910121	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature