FDA.reportPublic FDA data

Vent. Tube Diabolo Type Gold Platinum

Primary DI
EHKM10150511
Brand
Vent. Tube Diabolo Type Gold Platinum
Company
Heinz Kurz GmbH
Model
1015051
Catalog number
1015051
Device description
Middle ear implantable mould
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
ETDTube, Tympanostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973226000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973226000TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)Heinz Kurz GmbH Medizintechnik1997-11-04ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EHKM10150511PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Middle ear mouldingA preformed device intended to be implanted to reconstruct the middle ear cavity during repair of the tympanic membrane by permitting an ample air-filled cavity to be maintained in the middle ear; it also promotes regeneration of the mucous membrane lining of the middle ear cavity. It is typically made of synthetic polymer materials [e.g., polyamide, polytetrafluoroethylene (PTFE), silicone elastomer or polyethylene (PE)].

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

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Primary DI, Brand, Company table
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