Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277028752
• Version / Model: 560502
• Catalog Number: 560502
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-15
• Public Version: 1
• Public Version Date: 2019-01-15
• Public Version Status: New
• Public Device Record Key: 4bd24a2b-dee0-498b-9d7f-403acc674eba

Device Description

Splint Child Fracture-Pak

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
OHO	First aid kit without drug	General, Plastic Surgery	878.4014	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17983	Infectious waste spill kit	A set of devices used to clean up spillage of infectious material. It provides equipment and material for an appropriate method for removing the spillage, and includes the proper container for the disposal of the spillage. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277028752	GS1