MEDICOM SAFETOUCH

Basic Information

• Brand Name: MEDICOM SAFETOUCH
• Primary DI: 20686864054713
• Version / Model: SP-DAM-BL
• Catalog Number: SP-DAM-BL
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 2
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: c3f796c9-924f-45ac-bec0-e4e4e4462616
• Distribution End Date: 2024-02-05

Device Description

MEDICOM SAFETOUCH DENTAL DAM

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
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
Primary	20686864054713	GS1
Unit of Use	00686864054719	GS1

Customer Contacts

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

Storage Conditions

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