ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330703199
• Version / Model: PCHCAS22
• Catalog Number: PCHCAS22
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-28
• Public Version: 1
• Public Version Date: 2023-12-06
• Public Version Status: New
• Public Device Record Key: a888f0b4-98bf-4ff8-86ff-081cc1129ec7

Device Description

ProCure - Calcium Alginate with Silver 2"x2" 10ea/bx 120bx/cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
59522	Wound hydrogel dressing, antimicrobial	A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840330703193	GS1	Box	10	In Commercial Distribution
Primary	10840330703199	GS1
Package	50840330703197	GS1	Case	120	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	2	Inch
Width	2	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 32 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Avoid Freezing & Direct Sunlight