AMD-RITMED SOLON

Basic Information

• Brand Name: AMD-RITMED SOLON
• Primary DI: 10686864048647
• Version / Model: 50000
• Catalog Number: 50000
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 1
• Public Version Date: 2019-02-18
• Public Version Status: New
• Public Device Record Key: 67e73194-fd0c-4356-946f-14ee2b1f1135

Device Description

AMD-RITMED SOLON JUNIOR TONGUE DEPRESSORS 5.5 inch

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
42461	Tongue depressor, examination, single-use	A hand-held device 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 then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864048644	GS1	Outer Case	10	In Commercial Distribution
Primary	10686864048647	GS1
Unit of Use	00686864048640	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone] ext. 2309
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5.5 inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room temperature
• Type: Storage Environment Humidity
• Temperature Range: High: 80 Percent (%) Relative Humidity