Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780509431
• Version / Model: 35-505
• Catalog Number: 35-505
• 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: 2018-10-23
• Public Version: 4
• Public Version Date: 2022-07-15
• Public Version Status: Update
• Public Device Record Key: 4b7045c9-387e-4897-ac55-8f5cc3b8c3e3
• Distribution End Date: 2022-05-01

Device Description

Spoon Forceps, Spring Handle, Stainless Steel, Non-Insulated, Single Action Jaws, 10mm Outer Diameter, 35cm Working Length

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
NWV	Laparoscopic accessories, gynecologic	Obstetrics/Gynecology	884.1720	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834355050	HIBCC
Primary	10381780509431	GS1

Customer Contacts

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