A.M.I. Toggle Holder

Basic Information

• Brand Name: A.M.I. Toggle Holder
• Primary DI: EAMIGBC3650
• Version / Model: GBC 365
• Catalog Number: GBC 365
• Company Name: AMI Agency for Medical Innovations GmbH
• Labeler DUNS: 303655286
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-28
• Public Version: 3
• Public Version Date: 2023-01-02
• Public Version Status: Update
• Public Device Record Key: f9615a67-a2ad-4c06-b96e-463fece3b8df
• Distribution End Date: 2022-12-31

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: Yes
• Has Expiration Date: Yes
• 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
FZT	Cutter, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11290	Open-surgery dissector	A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used to separate a soft tissue or body structure from another. It is used in general or plastic surgery and is usually designed with a handle which continues into a shaft that terminates at the distal end with a tip. The tip may be pointed or flat, sharp or blunt, and angled or straight from the shaft. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EAMIGBC3650	HIBCC