AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864043888
• Version / Model: 83841
• Catalog Number: 83841
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 2
• Public Version Date: 2023-09-28
• Public Version Status: Update
• Public Device Record Key: a3b0f045-3fa6-4e71-af3a-3eedbfb2efe9
• Distribution End Date: 2023-09-27

Device Description

AMD-RITMED COTTON BALL X-RAY DETECTABLE 1 1/4 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63281	Cotton wool ball	A non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use as a swab to apply medications to or remove fluid/liquid from various parts of the body. It is intended for use in the home or a clinical setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864043885	GS1	Outer Case	20	Not in Commercial Distribution	2023-09-27
Primary	10686864043888	GS1
Unit of Use	00686864043881	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			1 1/4 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place