AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864044489
• Version / Model: 85997C
• Catalog Number: 85997C
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 1
• Public Version Date: 2019-02-15
• Public Version Status: New
• Public Device Record Key: e000eac6-b296-482e-9222-3cd59f950f80

Device Description

AMD-RITMED NEURO SPONGE SINGLE STRUNG X-R DETECTABLE 1 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	20686864044486	GS1	Outer Case	10	In Commercial Distribution
Primary	10686864044489	GS1
Unit of Use	00686864044482	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 X 3 Inch

Storage Conditions

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