AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864044335
• Version / Model: 85940C
• Catalog Number: 85940C
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 2
• Public Version Date: 2023-08-31
• Public Version Status: Update
• Public Device Record Key: 438d92b6-f815-4359-962e-aea8d8dedcd5
• Distribution End Date: 2023-08-30

Device Description

AMD-RITMED NEURO SPONGE SINGLE STRUNG X-R DETECTABLE 3 X 3 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
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864044332	GS1	Outer Case	10	Not in Commercial Distribution	2023-08-30
Primary	10686864044335	GS1
Unit of Use	00686864044338	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 X 3 Inch

Storage Conditions

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