Pomee

Basic Information

• Brand Name: Pomee
• Primary DI: G1577133060
• Version / Model: 713-306
• Catalog Number: 713-306
• Company Name: POMEE CORPORATION
• Labeler DUNS: 645717646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-11
• Public Version: 1
• Public Version Date: 2023-10-19
• Public Version Status: New
• Public Device Record Key: 0181c7d5-194a-4960-ba7d-0ffaa07d5ed7

Device Description

PK THOMAS WAX #1 - #5 (SET OF 5)

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: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIK	Carver, Wax, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35794	Dental wax carver	A hand-held manual dental instrument used to carve wax patterns with a blunt blade of varying size and shape, which can be heated for softening the wax while fashioning the pattern. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G1577133060	HIBCC