Test Weight Set Upper Eyelid Implant

Basic Information

• Brand Name: Test Weight Set Upper Eyelid Implant
• Primary DI: EHKM80001111
• Version / Model: 8000111
• Catalog Number: 8000111
• Company Name: Heinz Kurz GmbH
• Labeler DUNS: 341155720
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-07
• Public Version: 1
• Public Version Date: 2026-04-15
• Public Version Status: New
• Public Device Record Key: aaa385b8-99c6-4026-926b-32ffb16c8a0f

Device Description

Weights, eyelid, external

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: No
• 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
MML	Weights, Eyelid, External	Ophthalmic	886.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44067	ENT surgical procedure kit, non-medicated, reusable	A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EHKM80001111	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001123	000