MEDICOM SAFEBASICS

Basic Information

• Brand Name: MEDICOM SAFEBASICS
• Primary DI: 20686864048170
• Version / Model: 3015
• Catalog Number: 3015
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-01-24
• Public Version: 2
• Public Version Date: 2022-05-03
• Public Version Status: Update
• Public Device Record Key: dd68abe7-38c2-4983-8f5b-9ea4484cfa23

Device Description

MEDICOM SAFEBASICS HEADREST COVER 10 X 10 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRU	CHAIR, DENTAL, WITHOUT OPERATIVE UNIT	Dental	872.6250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20686864048170	GS1
Unit of Use	00686864048176	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			10 X 10 Inch

Storage Conditions

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