CALIPER

Basic Information

• Brand Name: CALIPER
• Primary DI: 00192896090286
• Version / Model: 12-9425
• Catalog Number: 12-9425
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-13
• Public Version: 3
• Public Version Date: 2019-10-03
• Public Version Status: Update
• Public Device Record Key: 2063647c-35eb-4476-9561-7d00a9480636

Device Description

CALIPER WITH DEPTH GAUGE MINIATURE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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, Dry Heat Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
16345	Exophthalmometer	An ophthalmic instrument used to measure the degree of exophthalmos (abnormal protrusion of the eyeball). It may be designed in the form of a ruler, gauge, or calliper. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896090286	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			90 Millimeter Scale
Device Size Text, specify			Range 5 Inch