HEDY DENTAL DAM

Basic Information

• Brand Name: HEDY DENTAL DAM
• Primary DI: 10686864060335
• Version / Model: 310DB-6M
• Catalog Number: 310DB-6M
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2024-08-27
• Public Version: 1
• Public Version Date: 2024-09-04
• Public Version Status: New
• Public Device Record Key: 012ce77f-771d-48d5-a6ee-3c576303fc42

Device Description

HEDY DENTAL DAM - Natural Rubber Latex - 6" x 6" - Medium - Blue

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIE	Dam, Rubber	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11155	Rubber dam, Hevea-latex	A sheet of elastomeric material made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00686864060338	GS1
Primary	10686864060335	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6" X 6"