Cranberry

Basic Information

• Brand Name: Cranberry
• Primary DI: 10817508022543
• Version / Model: CR8266
• Company Name: ASCEND EAGLE INCORPORATED
• Labeler DUNS: 167102750
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 36
• Record Status: Published
• Publish Date: 2021-12-27
• Public Version: 3
• Public Version Date: 2022-06-23
• Public Version Status: Update
• Public Device Record Key: 368fbee2-fd59-466e-8655-22428f8e28f7

Device Description

Cranberry Carbon Latex Scented Powder Free Dental Dam 36 /BX , 6"x6"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
Unit of Use	00817508022546	GS1
Primary	10817508022543	GS1
Package	20817508022540	GS1	Case	40	In Commercial Distribution

Customer Contacts

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