PREMIER VALUE

Basic Information

• Brand Name: PREMIER VALUE
• Primary DI: 00840986016547
• Version / Model: 97205CD
• Company Name: PHARMACY VALUE ALLIANCE, LLC
• Labeler DUNS: 089138159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• Record Status: Published
• Publish Date: 2020-09-21
• Public Version: 1
• Public Version Date: 2020-09-29
• Public Version Status: New
• Public Device Record Key: 91ebffa9-67a8-49c0-ae40-1c9aa6faa7cb

Device Description

PVA ASSORT FINGER COVERS

Device Characteristics

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

Sterilization

• Is Sterile: No
• 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
31978	Finger-cot surgical drape	A protective covering made of latex designed to isolate a urological/gynaecological surgical site from contamination (e.g., microbial, substance), that has a projection (finger cot) retained within the rectum or vagina to allow repeated insertion of the surgeon's finger into the rectum (e.g., during a transurethral prostatectomy) or vagina, keeping the glove of the surgeon from being contaminated. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20840986016541	GS1	INNER	6	In Commercial Distribution
Primary	00840986016547	GS1
Package	10840986016544	GS1	case	12	In Commercial Distribution
Unit of Use	48409860165438	GS1

Customer Contacts

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