Comfortear™

Basic Information

• Brand Name: Comfortear™
• Primary DI: 10810003223620
• Version / Model: 32-2005
• Catalog Number: 32-2005
• Company Name: MICROSPECIALITIES, INC.
• Labeler DUNS: 013469890
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2019-01-03
• Public Version: 2
• Public Version Date: 2020-01-13
• Public Version Status: Update
• Public Device Record Key: 79b22095-f765-4a2b-8de3-b4a6d43be3eb

Device Description

Comfortear™ Punctum Plugs economical bulk pack contain twenty (20) individually packaged non-sterile plugs per poly bag. X-Small, 0.6mm.

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: No
• PM Exempt: No
• 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
LZU	Plug, Punctum	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
36237	Lacrimal punctum plug	A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810003223620	GS1
Unit of Use	00810003223623	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.6	Millimeter