ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330703229
• Version / Model: PCHCAS12
• Catalog Number: PCHCAS12
• 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: 0353050d-9503-47f3-bd25-c620dedf4436

Device Description

ProCure - Calcium Alginate w/ Silver 12" Rope - 5ea/bx 40bx/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	30840330703223	GS1	Box	5	In Commercial Distribution
Primary	10840330703229	GS1
Package	50840330703227	GS1	Case	40	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	12	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