FDA.reportPublic FDA data

Sizer OMEGA CONNECTOR

Primary DI
14250368862557
Brand
Sizer OMEGA CONNECTOR
Company
Heinz Kurz GmbH
Model
8000555
Catalog number
8000555
Device description
Instrument Tympanoplasty Prostheses, Steel 1.4021 / 1.4310, length: 161mm
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYJGauge, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250368862557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425036886255714250368862557

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
Premarket exempt
true
Lot or batch
true
Serial number
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
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
EHKM10150031Vent. Tube Tuebingen Type Gold Platinum101500310150032015-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00757770501274Bausch + LombBausch & Lomb IncorporatedJYJ2025-06-03
00194613116965MSI Precision Specialty InstrumentsMed Saver, Inc.JYJ2025-03-21
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolFreudenberg Medical, LLCJYJ2025-03-14
00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482114223Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-20
00887482113387Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-12
00190776378448MillenniumAvalign Technologies, Inc.JYJ2023-11-13
00844505014328BENSON UNIVERSAL IMPLANT SIZERGrace Medical, Inc.JYJ2023-09-27
00190776289232MillenniumAvalign Technologies, Inc.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
04250381854891Castroviejo nasal caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250676733726Joseph placing instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250381848401Fisch reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848456Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848463Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381848470Fisch reference caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849453Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849460Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13
04250381849477Reference instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-13