ProCure

Basic Information

• Brand Name: ProCure
• Primary DI: 10840330706176
• Version / Model: PCHCMDS44
• Catalog Number: PCHCMDS44
• Company Name: Twin Med, LLC
• Labeler DUNS: 107071289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-08
• Public Version: 1
• Public Version Date: 2026-04-16
• Public Version Status: New
• Public Device Record Key: 3bf3fc3c-47e8-45b6-abf1-25f7e9d14339

Device Description

ProCure Healing AG Collagen Matrix Dressing with Silver 4"x4" - 10ea/bx 10bx/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
45023	Animal-derived wound matrix dressing	A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30840330706170	GS1	Box	10	In Commercial Distribution
Primary	10840330706176	GS1
Package	50840330706174	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060804	000

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Height	10	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry and away from direct sunlight