Karl Schumacher

Basic Information

• Brand Name: Karl Schumacher
• Primary DI: 00842517107434
• Version / Model: CRE0134
• Company Name: Karl Schumacher Dental, LLC
• Labeler DUNS: 101070070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-06
• Public Version: 1
• Public Version Date: 2024-05-14
• Public Version Status: New
• Public Device Record Key: 61b56ccf-ed1a-4e93-816f-0b47097138ad

Device Description

Crwn Remover, Elite Hdl, Ofst45 Blades

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64132	Medical equipment handle cover adaptor	A connecting device intended to be used to connect the handle of a piece of medical equipment (e.g., operating light) with a handle cover, when these are incompatible and are of a different manufacture/industry standard. It is made of polymer and/or metallic materials and takes a form suitable for the devices to which it connects. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842517107434	GS1

Customer Contacts

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