Integra® Miltex®

Basic Information

• Brand Name: Integra® Miltex®
• Primary DI: 10381780448860
• Version / Model: 27-3020
• Catalog Number: 27-3020
• Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION
• Labeler DUNS: 081277700
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-26
• Public Version: 5
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: c277f695-582e-42a4-9462-d9b35e05c676

Device Description

Integra® Miltex® Engel Cast Saw 5-5/8"

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
LGG	INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL	Orthopedic	888.5980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15774	Cast cutter blade	A surgical cutting device intended to be used with a cast removal tool (cast cutter) to provide the cutting edge for cutting through cast material so that this can be removed from the patient. It is formed as a thin, rounded, half moon-like, or circular blade with serrated teeth around its cutting edge. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H8342730200	HIBCC
Primary	10381780448860	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5-7/8"