FDA.reportPublic FDA data

Vent. Tube Tuebingen Type Gold-plated Ag

Primary DI
EHKM10150101
Brand
Vent. Tube Tuebingen Type Gold-plated Ag
Company
Heinz Kurz GmbH
Model
1015010
Catalog number
1015010
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
EHKM10150101PrimaryHIBCC0

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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