Pomee

Basic Information

• Brand Name: Pomee
• Primary DI: G1577072000
• Version / Model: 707-200
• Catalog Number: 707-200
• Company Name: POMEE CORPORATION
• Labeler DUNS: 645717646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-30
• Public Version: 1
• Public Version Date: 2022-01-07
• Public Version Status: New
• Public Device Record Key: bf32ff88-7c19-4ba8-8f3f-73b7e064878a

Device Description

MIRROR # 4 CONE SOCKET F/S 12/PACK

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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EAX	Mirror, Mouth	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31176	Tactile orientation material	A device used by a person with a disability who has an impaired sense of orientation, typically a blind person, to self-orient in their surroundings, e.g., at home, work, and in the normal daily life of society. It consists of special tactile-material, including structured surfaces, to provide the user with information pertaining to their surroundings and function as signs to provide the user with known orientation points.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G1577072000	HIBCC