Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00817617028446
• Version / Model: 8600-01249
• Catalog Number: 8600-01249
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-13
• Public Version: 3
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: 253f0ba5-1f0c-4df0-bdb2-91964f8b68b1

Device Description

*Custom* Curaplex Clemson Univ. Fire IV Start Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
MCY	Wound dressing kit	General Hospital	880.5075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10516	Burn kit, non-medicated	A collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817617028446	GS1