Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780441595
• Version / Model: 30-5003
• Catalog Number: 30-5003
• 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: 7a11ed03-a1b6-45c2-85ea-48dce889ca50

Device Description

Integra® Miltex® Disposable Fundus Sound, 8-1/2"

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
HHM	SOUND, UTERINE	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46435	Uterine sound, single-use	A sterile, hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8343050031	HIBCC
Primary	10381780441595	GS1
Unit of Use	00381780441598	GS1

Customer Contacts

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