Müller introducer

Basic Information

• Brand Name: Müller introducer
• Primary DI: 04250381849545
• Version / Model: 10-660-00
• Catalog Number: 10-660-00
• Company Name: Spiggle & Theis Medizintechnik GmbH
• Labeler DUNS: 332893028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-13
• Public Version: 1
• Public Version Date: 2022-09-21
• Public Version Status: New
• Public Device Record Key: 78ff6030-1487-4685-92fe-fd2470baf1c4

Device Description

for cochlea implants, straight golden handle, 18 cm

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: Yes
• 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: Yes
• 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
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61446	Cochlear electrode array introducer, reusable	A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04250381849545	GS1

Customer Contacts

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