MEDICOM SAFEBASICS

Basic Information

• Brand Name: MEDICOM SAFEBASICS
• Primary DI: 10686864048500
• Version / Model: 4440
• Catalog Number: 4440
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2019-01-15
• Public Version: 3
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: 1393427d-af51-42c3-8104-a9edc2dc0499
• Distribution End Date: 2023-08-01

Device Description

MEDICOM SAFEBASICS NON-WOVEN SPONGES 4PLY 4 X 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
NAC	Dressing, wound, hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864048507	GS1	Outer Case	12	Not in Commercial Distribution	2023-08-01
Package	12686864048508	GS1	Tray	50	Not in Commercial Distribution	2023-08-01
Primary	10686864048500	GS1
Unit of Use	00686864048503	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			4 x 4 Inch

Storage Conditions

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