Penlight

Basic Information

• Brand Name: Penlight
• Primary DI: 00786511076566
• Version / Model: S214-SIL
• Company Name: RASHMAN CORPORATION
• Labeler DUNS: 078803608
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 8a7aed38-c6da-493e-87ad-2192bbb6461c

Device Description

Soft LED Pupil Gauge Penlight

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYT	Light, Examination, Medical, Battery Powered	General Hospital	880.6350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61740	Corneal marker handpiece	A manually-operated instrument intended to be used with a disposable handpiece tip (not included) to ink mark corneal tissue prior to an ophthalmic surgical procedure. It is a pen-like device with a weighted, self-levelling mechanism intended to accept the ink-loaded tip; it may include a battery-powered fixation light intended to draw the patient’s focus during the marking procedure. It is not intended to directly contact the eye. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00786511076566	GS1