ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330703878
• Version / Model: PCSPNS02
• Catalog Number: PCSPNS02
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-21
• Public Version: 1
• Public Version Date: 2024-02-29
• Public Version Status: New
• Public Device Record Key: ebee8f83-ec9b-4572-b31c-1db6b50af4d1

Device Description

ProCure No Sting Barrier Film Skin Prep/Protectant Spray 2oz 12ea/bx 12bx/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: Yes
• Has Manufacturing Date: Yes
• 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
NEC	Bandage, Liquid, Skin Protectant	General Hospital	880.5090	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58978	Synthetic-polymer liquid barrier dressing	A liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840330703872	GS1	Box	12	In Commercial Distribution
Primary	10840330703878	GS1
Package	50840330703876	GS1	Case	12	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	35	Millimeter
Height	123	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from fire sources of ignition. Store in dry, ventilated environment. Store at room temperature.
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit