Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780063643
• Version / Model: 4-312B
• Catalog Number: 4-312B
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-02-14
• Public Version: 6
• Public Version Date: 2023-05-02
• Public Version Status: Update
• Public Device Record Key: 473c8a90-82ef-41cf-bd5f-b72b34c2501c

Device Description

Integra® Miltex® Stainless Steel Surgical Blades

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GES	BLADE, SCALPEL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8344312B1	HIBCC
Primary	10381780063643	GS1
Unit of Use	00381780063646	GS1

Customer Contacts

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