Young

Basic Information

• Brand Name: Young
• Primary DI: 00302731771014
• Version / Model: 177101
• Catalog Number: 177101
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• Labeler DUNS: 006309355
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-16
• Public Version: 1
• Public Version Date: 2022-10-24
• Public Version Status: New
• Public Device Record Key: 2e198522-3405-4d86-96c5-f5ad4e80cbb8

Device Description

Young Original Rubber Dam Frame, 7 Tines with 2 Floss Buttons,4 1/8 in. X 3 1/2 in. (10.4 cm x 9.2 cm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJE	FRAME, RUBBER DAM	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31849	Rubber dam frame	A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10302731771011	GS1	Box	1	In Commercial Distribution
Primary	00302731771014	GS1

Customer Contacts

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