FDA.reportPublic FDA data

Upper Eyelid Implant Platinum/Iridium

Primary DI
EHKM40070081
Brand
Upper Eyelid Implant Platinum/Iridium
Company
Heinz Kurz GmbH
Model
4007008
Catalog number
4007008
Device description
Eyelid weight, implantable
Published
2015-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
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
K011115000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011115000KURZ UPPER EYELID IMPLANT- PLATINUM/IRIDIUM,MODELS REGULAR 4007 003-007, SPECIAL 4007 002, 4007 008-010Heinz Kurz GmbH Medizintechnik2001-05-02MML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHKM40070081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid weight, implantableAn ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material [e.g., gold (Au), platinum (Pt)].

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
341155720
Device count
1
Lot or batch
true
Expiration date on label
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
EHKM80001111Test Weight Set Upper Eyelid ImplantHeinz Kurz GmbHMML2026-04-07
00813142021303BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021310BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021327BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021334BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021341BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021358BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021365BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021372BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021389BlinkezeMEDDEV CORPORATIONMML2023-11-28
00813142021396BlinkezeMEDDEV CORPORATIONMML2023-11-28
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