Stephens Instruments

Basic Information

• Brand Name: Stephens Instruments
• Primary DI: 00810061910909
• Version / Model: CSP-1003
• Catalog Number: CSP-1003
• Company Name: KRISHNA IMPORTS INC
• Labeler DUNS: 081853285
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2020-12-20
• Public Version: 1
• Public Version Date: 2020-12-28
• Public Version Status: New
• Public Device Record Key: a267da40-6b6d-4281-a316-861e2535b2cc

Device Description

VeraC7 Collagen Inserts - 0.3mm

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	00851807007279	GS1	box	10	In Commercial Distribution
Primary	00810061910909	GS1
Unit of Use	00810061910978	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K897190	000

Storage Conditions

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