HEDY DENTAL DAM

Basic Information

• Brand Name: HEDY DENTAL DAM
• Primary DI: 10686864060410
• Version / Model: 320DNB-5H
• Catalog Number: 320DNB-5H
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 30
• 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: e13b0d11-c0b5-4a5b-8a18-6778ebc48168

Device Description

HEDY Polyisoprene Dental Dam - Non-Latex - 5"x 5" - Heavy - 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: 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: Yes
• 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
45004	Rubber dam, non-latex	A sheet of elastomeric synthetic material (e.g., silicone) 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 device may be used for patients and/or staff that have an allergy to latex. 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	00686864060413	GS1
Primary	10686864060410	GS1
Package	20686864060417	GS1	Outer case	40	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone] ext. 2309
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 X 5 Inch