Pomee

Basic Information

• Brand Name: Pomee
• Primary DI: G15772445000
• Version / Model: 724-4500
• Catalog Number: 724-4500
• 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: dbb3cac1-573a-47ce-8779-c1e223f6c288

Device Description

Young Tongue Holder 6 1/4"

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
EFL	Forceps, Dressing, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62468	Surgical soft-tissue manipulation forceps, scissors-like, reusable	A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G15772445000	HIBCC