Quinelato

Basic Information

• Brand Name: Quinelato
• Primary DI: 07898506811595
• Version / Model: QD.195.00
• Catalog Number: QD.195.00
• Company Name: Schobell Industrial Ltda
• Labeler DUNS: 899060826
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-28
• Public Version: 2
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: ceecfbb1-e4e6-4eae-b33c-66d75709899b

Device Description

Wieder tongue depressor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63659	Tongue depressor, examination, reusable	A hand-held device intended to be used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make it less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898506811595	GS1