Pomee

Basic Information

• Brand Name: Pomee
• Primary DI: G1577165380
• Version / Model: 716-538
• Catalog Number: 716-538
• Company Name: POMEE CORPORATION
• Labeler DUNS: 645717646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-03
• Public Version: 1
• Public Version Date: 2022-01-11
• Public Version Status: New
• Public Device Record Key: f0ea5490-c5e3-4324-9d3c-ff8fb0b4dcd5

Device Description

Who probe ball tip (3.5-5.5-8.5-11.5 mm)

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
31848	Periodontal probe, reusable	A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G1577165380	HIBCC