Mi1200 Implant Template

Basic Information

• Brand Name: Mi1200 Implant Template
• Primary DI: 09008737097998
• Version / Model: 09799
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-02-28
• Public Version: 5
• Public Version Date: 2022-07-15
• Public Version Status: Update
• Public Device Record Key: c83d98ba-d6a9-4df3-837e-a14a0d52bda8

Device Description

Single-Use Surgical Tool

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MCM	IMPLANT, COCHLEAR	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58804	Surgical implant template, single-use	A device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737097998	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P000025	079
P000025	122

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 131 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: may only be stored in the sterile packaging inside the implant box at room temperature until the stated expiry date