Vitale

Basic Information

• Brand Name: Vitale
• Primary DI: 00850005565109
• Version / Model: 57509
• Catalog Number: 57509
• Company Name: CELLERA LLC
• Labeler DUNS: 960091929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-15
• Public Version: 4
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: f62fa3ac-926b-404b-8dd6-44d0b96ec8d4

Device Description

Xeroform Petrolatum Gauze Dressings, 5" x 9", 50/box, 8 boxes/case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48132	Petrolatum woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850005565113	GS1	case	8	In Commercial Distribution
Package	00850005565116	GS1	box	50	In Commercial Distribution
Primary	00850005565109	GS1

Customer Contacts

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