PremierPro

Basic Information

• Brand Name: PremierPro
• Primary DI: 00818566017116
• Version / Model: 7043
• Catalog Number: 7043
• 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: 797fd6ad-31bd-4ec1-b062-0f256c40861d

Device Description

Fiberglass Padded Safety Splint, 3" x 35" Pre-Cut Splint 15pc

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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• 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
33056	Cast construction material	A plastic, fibreglass, or plaster-containing substance (or other material) that is applied in layers around an injured body appendage to construct a stiff dressing (cast) in order to immobilize fractured bones, diseased joints, or painful sprains. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00818566017116	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid Direct Sunlight
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius