FDA.reportPublic FDA data

Test Weight Set Upper Eyelid Implant

Primary DI
EHKM80001111
Brand
Test Weight Set Upper Eyelid Implant
Company
Heinz Kurz GmbH
Model
8000111
Catalog number
8000111
Device description
Weights, eyelid, external
Published
2026-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMLWeights, Eyelid, External

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMLWeights, Eyelid, ExternalOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001123000KURZ UPPER EYELID IMPLANT SIZERS, MODEL 8000 111Heinz Kurz GmbH Medizintechnik2000-04-21MML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHKM80001111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49707291790info@kurzmed.com

Regulatory Flags#

DUNS number
341155720
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14250368820892Soft CliP Hook800012780001272026-05-21
14250368861062KURZ Meter incl. Tray800010680001062026-05-21
14250368861369Titanium Tweezers800013680001362026-05-21
14250368861376Titanium Micro Closing Forceps800013780001372026-05-21
14250368861406KURZ Precise Blades800014080001402026-05-21
14250368861437Trocar Handle800014380001432026-05-21
14250368861550KURZ Precise Cartilage Knife Set800015580001552026-05-21
14250368861710Cutting Forceps800017180001712026-05-21
14250368861727Micro Scissors800017280001722026-05-21
14250368861734Tray TTP-VARIAC800017380001732026-05-21
14250368861741Tray KURZ Meter800017480001742026-05-21
14250368861765Tray Cartilage Punch800017680001762026-05-21
14250368861932Cartilage Forceps Schimanski Design800019380001932026-05-21
14250368862007Cartilage Punch800020080002002026-05-21
14250368862557Sizer OMEGA CONNECTOR800055580005552026-05-21
14250368865404AC Sizer System Partial800054080005402026-05-21
14250368865503AC Sizer System Total800055080005502026-05-21
14250368885099SteadyCrimP Forceps800018880001882026-05-21
EHKM10150011Vent. Tube Tuebingen Type Gold Platinum101500110150012015-09-21
EHKM10150021Vent. Tube Tuebingen Type Gold Platinum101500210150022015-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00813142021303BlinkezeMEDDEV CORPORATIONMML2023-11-28
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00813142021372BlinkezeMEDDEV CORPORATIONMML2023-11-28
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00813142021402BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021419BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021426BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021433BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021440BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021457BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021464BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021471BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021488BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021495BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021501BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021518BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021525BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021532BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021549BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021556BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021563BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021570BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021587BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021594BlinkezeMEDDEV CORPORATIONMML2023-11-28