Pro-Paks

Basic Information

• Brand Name: Pro-Paks
• Primary DI: 10810003224443
• Version / Model: 1002PL
• Catalog Number: 1002PL
• Company Name: MICROSPECIALITIES, INC.
• Labeler DUNS: 013469890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2023-09-02
• Public Version: 1
• Public Version Date: 2023-09-11
• Public Version Status: New
• Public Device Record Key: 125dfd0e-77a8-49bc-b6c8-fa98a44c0e08

Device Description

“Solar Shield” fit over glasses, 20 per box

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65733	Postsurgical transparent eye shield, vented	A device designed to be worn over the eye to protect the eye while allowing the wearer to see, typically following ophthalmic surgery. It is designed as a transparent self-adhesive dome which includes vent holes to allow air to circulate around the eye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30810003224447	GS1	Box	20	In Commercial Distribution
Primary	10810003224443	GS1
Unit of Use	00810003224446	GS1

Customer Contacts

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