AMD-RITMED SOLON

Basic Information

• Brand Name: AMD-RITMED SOLON
• Primary DI: 20686864046060
• Version / Model: 57604
• Catalog Number: 57604
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-01-14
• Public Version: 3
• Public Version Date: 2023-05-31
• Public Version Status: Update
• Public Device Record Key: bd4d869e-5205-4db6-b60e-10a46cf656cb
• Distribution End Date: 2023-05-30

Device Description

AMD-RITMED SOLON RAYON TIPPED OB/GYN APPLICATORS 8 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
KXF	APPLICATOR, ABSORBENT TIPPED, NON-STERILE	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/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
Primary	20686864046060	GS1
Unit of Use	00686864046066	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8 Inch

Storage Conditions

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