AMD-RITMED SOLON

Basic Information

• Brand Name: AMD-RITMED SOLON
• Primary DI: 10686864048654
• Version / Model: 51100
• Catalog Number: 51100
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 2
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: 6680bfdf-dcde-4d17-8ee8-5b8c07fe54ce
• Distribution End Date: 2023-11-08

Device Description

AMD-RITMED SOLON INFANT TONGUE DEPRESSORS

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	20686864048651	GS1	Outer Case	10	Not in Commercial Distribution	2023-11-08
Primary	10686864048654	GS1
Unit of Use	00686864048657	GS1

Customer Contacts

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

Storage Conditions

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