SuperFlex

Basic Information

• Brand Name: SuperFlex
• Primary DI: 00841668115015
• Version / Model: 3172J
• Catalog Number: 3172J
• Company Name: KATENA PRODUCTS, INC.
• Labeler DUNS: 085668598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-31
• Public Version: 4
• Public Version Date: 2022-02-21
• Public Version Status: Update
• Public Device Record Key: 5d8c9791-c72e-472f-886a-1dbc89e7632d

Device Description

SuperFlex Punctum Plug 1.2mm D x 2.0mm L - Twin Pack

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
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	00841668115015	GS1

Customer Contacts

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