Miltex®

Basic Information

• Brand Name: Miltex®
• Primary DI: 10381780038306
• Version / Model: 62-308
• Catalog Number: 62-308
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 5
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 5875ef66-0672-4ce2-8147-150eef86af11
• Distribution End Date: 2017-03-20

Device Description

MIXING CUP, STAINLESS WITH PLASTIC LID

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: No
• 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
DZL	SCREW, FIXATION, INTRAOSSEOUS	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45119	Dappen dish, reusable	A small, shallow, hand-held concave vessel made of glass or metal used to mix dental materials chairside prior to application to the patient during dental procedures. The user dispenses the required amount of component materials into the device and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834623080	HIBCC
Primary	10381780038306	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092855	000