MEDICOM SAFETOUCH

Basic Information

• Brand Name: MEDICOM SAFETOUCH
• Primary DI: 10686864047428
• Version / Model: 1266HB
• Catalog Number: 1266HB
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 2
• Public Version Date: 2023-06-13
• Public Version Status: Update
• Public Device Record Key: 604e5001-4e24-4912-a2de-2d034115bbd3
• Distribution End Date: 2023-06-12

Device Description

MEDICOM SAFETOUCH DENTAL DAM 6 X 6 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: 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: 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
Package	20686864047425	GS1	Outer Case	6	Not in Commercial Distribution	2023-06-12
Primary	10686864047428	GS1
Unit of Use	00686864047421	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			6 X 6 Inch

Storage Conditions

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