Pomee

Basic Information

• Brand Name: Pomee
• Primary DI: G1577047610
• Version / Model: 704-761
• Catalog Number: 704-761
• 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: c3e9d4fe-f78a-4ff8-8c6a-199c14d904b8

Device Description

Excavator #61/62

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
EIX	Probe, Periodontic	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35811	Dental excavator, reusable	A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G1577047610	HIBCC