AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864047510
• Version / Model: DI-16-DIS-B
• Catalog Number: DI-16-DIS-B
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-13
• Public Version: 1
• Public Version Date: 2019-02-13
• Public Version Status: New
• Public Device Record Key: 6c81a5ba-5fdb-478b-a6c9-31697033f4e5
• Distribution End Date: 2019-01-13

Device Description

AMD-RITMED DERMAFILL WOUND DRESSING 4 X 6 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: Yes
• Not Made with NRL: No
• 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
NAC	Dressing, wound, hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58304	Biopolysaccharide semi-permeable film dressing	A sterile, transparent, semi-permeable (i.e., impermeable to fluids, permeable to vapours and gases) covering applied to wounded or diseased tissue intended to provide protection (e.g., from dirt, microbes) and/or promote healing. It is a thin, clear, hydrophilic membrane made of a biopolysaccharide (e.g., a matrix of microbe-derived cellulose) without an adhesive. It is typically applied directly to tissue to protect and/or help heal burns, skin-graft donor sites, ulcers, or other partial-thickness wounds. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864047517	GS1	Outer Case	12	Not in Commercial Distribution	2019-01-13
Primary	10686864047510	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			4 X 6 Inch

Storage Conditions

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