SOLON

Basic Information

• Brand Name: SOLON
• Primary DI: 10686864048777
• Version / Model: 51510
• Catalog Number: 51510
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 2
• Public Version Date: 2023-11-17
• Public Version Status: Update
• Public Device Record Key: 86226ff3-1fa3-40a6-ad48-401e03e82abc
• Distribution End Date: 2023-11-16

Device Description

SolonCare - Non-Sterile Wooden Spoons - 3 5/8"

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
ILC	Utensil, Eating	Physical Medicine	890.5050	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	20686864048774	GS1	Outer case	10	Not in Commercial Distribution	2023-11-16
Primary	10686864048777	GS1
Unit of Use	00686864048770	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			3 5/8 inch