VELNEZ

Basic Information

• Brand Name: VELNEZ
• Primary DI: 08904340407616
• Version / Model: 140402
• Company Name: DATT MEDIPRODUCTS PRIVATE LIMITED
• Labeler DUNS: 650733074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-21
• Public Version: 1
• Public Version Date: 2023-06-29
• Public Version Status: New
• Public Device Record Key: 5da90fa8-d432-4c51-b5a0-4e4b59e7a05f

Device Description

VELNEZ Nasal Pack 4 cm x 2 cm

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LYA	Splint, Intranasal Septal	Ear, Nose, Throat	874.4780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64402	Intranasal splint, non-bioabsorbable, animal-derived	A non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08904340407616	GS1

Device Sizes

Type	Value	Unit	Text
Length	4	Centimeter
Width	2	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 30 Degrees Celsius