Hahnenkratt

Basic Information

• Brand Name: Hahnenkratt
• Primary DI: E20641X131
• Version / Model: 41X13
• Company Name: E. Hahnenkratt GmbH
• Labeler DUNS: 316001098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2024-09-10
• Public Version: 1
• Public Version Date: 2024-09-18
• Public Version Status: New
• Public Device Record Key: 1c817335-ca4e-4edd-95a9-b71c463534da

Device Description

100-Pack: Ivory No. 13

Device Characteristics

• Single Use: Yes
• 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: 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
KCQ	Tube Impression And Matrix	Dental	872.6570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E20641X131	HIBCC
Unit of Use	E20641X130	HIBCC