Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780488293
• Version / Model: MH30-50
• Catalog Number: MH30-50
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-20
• Public Version: 3
• Public Version Date: 2023-04-28
• Public Version Status: Update
• Public Device Record Key: cc6fd44a-663e-44d8-953c-6d6605b08365

Device Description

Integra® Miltex® Pederson Vaginal Speculum, 1/2" x 3-1/4", Small Blades

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
HDF	SPECULUM, VAGINAL, METAL	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35352	Vaginal speculum, reusable	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834MH30500	HIBCC
Primary	10381780488293	GS1

Customer Contacts

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