SOFT PLUG® Silicone Punctum Plug

Basic Information

• Brand Name: SOFT PLUG® Silicone Punctum Plug
• Primary DI: 00845819000229
• Version / Model: 6614-SFC, 6614-FC
• Company Name: OASIS MEDICAL, INC.
• Labeler DUNS: 194121018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-30
• Public Version: 1
• Public Version Date: 2023-07-10
• Public Version Status: New
• Public Device Record Key: 58b8cd00-2fb3-403c-9d36-3cc2d2322ad9

Device Description

SOFT PLUG® Silicone Punctum Plug, Flow Control, Medium (0.8 mm)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

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
Package	10845819000226	GS1	Carton	1	In Commercial Distribution
Primary	00845819000229	GS1
Package	20845819000223	GS1	Carton	2	In Commercial Distribution

Customer Contacts

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