PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566017567
• Version / Model: 3631
• Catalog Number: 3631
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-04
• Public Version: 2
• Public Version Date: 2022-06-21
• Public Version Status: Update
• Public Device Record Key: c0a125f1-1e79-41d2-bc22-db1d5a05f48e

Device Description

Maternity Pad, 10.5"x4", 16/bg

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	884.5435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40545	Menstrual pad, unscented	A non-deodorized, feminine hygiene product (a pad) that is held in place externally to absorb menstrual or other vaginal discharge. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818566017564	GS1	case	12	In Commercial Distribution
Primary	00818566017567	GS1

Customer Contacts

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