CareALL

Basic Information

• Brand Name: CareALL
• Primary DI: 00085317005795
• Version / Model: DA85
• Company Name: NEW WORLD IMPORTS, INC.
• Labeler DUNS: 075372276
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-11
• Public Version: 1
• Public Version Date: 2020-08-19
• Public Version Status: New
• Public Device Record Key: b6e35186-7421-4397-a608-015f07e3c7e1

Device Description

CareALL® .85 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
KOO	Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	Dental	872.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46127	Carboxymethylcellulose sodium/polymer denture adhesive, zinc-free	An adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00085317005788	GS1	Box	24	In Commercial Distribution
Primary	00085317005795	GS1
Package	00085317005771	GS1	Case	3	In Commercial Distribution

Customer Contacts

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