PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566017314
• Version / Model: 7004
• Catalog Number: 7004
• Company Name: SVS LLC
• Labeler DUNS: 831375089
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-29
• Public Version: 1
• Public Version Date: 2020-09-07
• Public Version Status: New
• Public Device Record Key: fc5ff3ba-dd77-4fbc-a9f2-13d6e20b3ab3

Device Description

Water Resistant Padding, 4" x 2.6 yds, 12 rolls/bx, 6 bx/cs

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
ITG	Bandage, Cast	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33536	Cast/bandage waterproof bathing cover, single-use	A device made of waterproof materials designed to be placed over a treated area of the body, typically a plaster cast, stitches, bandage, dressing, or PICC line, to keep the area dry while the user is having a shower or a bath. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818566017314	GS1

Customer Contacts

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