Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780450757
• Version / Model: DEFXCR34M
• Catalog Number: DEFXCR34M
• 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: 2018-02-26
• Public Version: 4
• Public Version Date: 2020-02-05
• Public Version Status: Update
• Public Device Record Key: bdf388a0-cdf3-4c28-8723-ddd9d7ddb6bc
• Distribution End Date: 2018-12-28

Device Description

Extracting Forceps 34M, Xcision™ RoBa

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
EMG	FORCEPS, TOOTH EXTRACTOR, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35552	Tooth extraction forceps	A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H834DEFXCR34M0	HIBCC
Primary	10381780450757	GS1

Customer Contacts

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