MEDICOM

Basic Information

• Brand Name: MEDICOM
• Primary DI: 10686864048555
• Version / Model: 4554
• Catalog Number: 4554
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2000
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 48157d07-e9f5-4b8e-97e1-d3864a2b790c
• Distribution End Date: 2023-09-06

Device Description

MEDICOM COTTON DENTAL ROLL 1 1/2 X 3/8 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
EFN	COTTON, ROLL	Dental	872.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31815	Dental cotton roll	A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864048552	GS1	Outer Case	12	Not in Commercial Distribution	2023-09-06
Primary	10686864048555	GS1
Unit of Use	00686864048558	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 1/2 X 3/8 Inch

Storage Conditions

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