Safco DENTA-SAFE NON-LATEX DENTAL DAM

Basic Information

• Brand Name: Safco DENTA-SAFE NON-LATEX DENTAL DAM
• Primary DI: 10810063750159
• Version / Model: 1020777
• Catalog Number: 1020777
• Company Name: SAFCO DENTAL SUPPLY CO.
• Labeler DUNS: 020417380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-04-13
• Public Version: 1
• Public Version Date: 2022-04-21
• Public Version Status: New
• Public Device Record Key: 7e082fd2-6fd7-4aec-a125-1b9fcab2b336

Device Description

Heavy (0.23mm-0.28mm thickness) 5" x 5", box of 20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• 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
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	00810063750152	GS1
Primary	10810063750159	GS1