Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780441601
• Version / Model: 30-5002
• Catalog Number: 30-5002
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2018-02-28
• Public Version: 3
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: 0b69915f-1102-4d9b-a79c-c2ee0e41a75f

Device Description

Integra® Miltex® Disposable Canal Dilator, 8-12"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HDQ	DILATOR, CERVICAL, FIXED SIZE	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47987	Fixed-diameter cervical dilator, single-use	A rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8343050021	HIBCC
Primary	10381780441601	GS1
Unit of Use	00381780441604	GS1

Customer Contacts

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