Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810061910794
• Version / Model: VFF-5002
• Catalog Number: VFF-5002
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 2a9b78d1-b6a6-4ab4-a476-6c27ea67bfdb

Device Description

VeraPlug FlexFit Sterile Preloaded - Medium

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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

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	00810799030030	GS1	box	2	In Commercial Distribution
Primary	00810061910794	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K140352	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature