Curaplex

Basic Information

• Brand Name: Curaplex
• Primary DI: 00815277021517
• Version / Model: 670050-KIT
• Catalog Number: 670050-KIT
• Company Name: BOUND TREE MEDICAL, LLC
• Labeler DUNS: 070556204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-14
• Public Version: 3
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: a494521f-c4d3-4d23-8853-5fb3b1f9ab9a

Device Description

Curaplex Opioid Training 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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2
CCT	APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA	Anesthesiology	868.5170	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60502	Atomizing surgical topical solution applicator	A sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00815277021517	GS1
Package	00810094570682	GS1	CS	100	In Commercial Distribution