Depressors

Basic Information

• Brand Name: Depressors
• Primary DI: 16973069980013
• Version / Model: NA
• Company Name: Dalian Rongbang Medical Healthy Devices Co., Ltd.
• Labeler DUNS: 529882730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-09-07
• Public Version: 2
• Public Version Date: 2023-05-24
• Public Version Status: Update
• Public Device Record Key: 830f84b6-8d44-479b-8952-b026ba9497e2

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMA	Depressor, Tongue, Non-Surgical	General Hospital	880.6230	1

GMDN Terms

Code	Name	Definition	Implantable	Status
14066	Tongue depressor, surgical	A hand-held surgical instrument designed to displace and maintain the tongue in a fixed position, usually by depressing it towards the floor of the mouth. It is typically a metallic (e.g., high-grade stainless steel) device either with a straight shape, or more frequently smoothly bent at its center (e.g., to a 90? arch). The proximal end is used as a handle, while the distal end (usually serrated and may include holes) is used to depress the tongue. The device is used in oral surgery (e.g., during tonsillectomy). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	26973069980010	GS1
Primary	16973069980013	GS1