Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780495932
• Version / Model: 7625
• Catalog Number: 7625
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-24
• Public Version: 3
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: faf26f6a-e66c-4b84-a0d6-ce689b9cfb61

Device Description

Integra® Miltex® Rubber Dam Frame Holder

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: No
• 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
Secondary	H83476250	HIBCC
Primary	10381780495932	GS1

Customer Contacts

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