iCAP Imaging Cap

Basic Information

• Brand Name: iCAP Imaging Cap
• Primary DI: 00893872001028
• Version / Model: IC-100
• Catalog Number: 200549
• Company Name: Nova Eye, Inc.
• Labeler DUNS: 079755637
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 4
• Public Version Date: 2020-12-08
• Public Version Status: Update
• Public Device Record Key: aac518e9-bf29-4a60-bef4-27c2721d9fc8
• Distribution End Date: 2017-11-30

Device Description

Imaging Cap

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	892.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43970	Cable/lead/sensor/probe cover, sterile	A sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	893872001462	GS1	Multiple Unit Box	15	Not in Commercial Distribution	2017-11-30
Primary	00893872001028	GS1

Customer Contacts

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