Mouth spacer

Basic Information

• Brand Name: Mouth spacer
• Primary DI: 03660381013753
• Version / Model: BS802-000SM-000
• Catalog Number: MZ/602
• Company Name: MEDICAL Z
• Labeler DUNS: 273431759
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-16
• Public Version: 1
• Public Version Date: 2024-04-24
• Public Version Status: New
• Public Device Record Key: 663aef31-5370-4982-9458-0a4ce2b09108

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
MDA	Elastomer, silicone, for scar management	General, Plastic Surgery	878.4025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
67090	Microstomia splinting appliance	A prefabricated device intended to be used in the mouth during a prescribed period of time to stretch apart the oral opening to prevent and/or treat microstomia, typically acquired from facial burns, radiation treatment or surgical scarring. Also referred to as a microstomia splint or commissural splint, it consists of a small appliance with an intraoral stretching portion, and two extraoral protruding shafts which enable patient self-adjustment; accessories such as elastic and static bands may be supplied with the device. This is a single-patient reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03660381013753	GS1

Customer Contacts

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