Device
Instrument Tympanoplasty Prostheses, Steel 1.4034 or Steel 1.4037, 43mm x 22mm x 0.1mm
Manufacturer
Heinz Kurz GmbH
Heinz Kurz GmbH
Model: 8000140
Catalog: 8000140
DI: 14250368861406
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Instrument Tympanoplasty Prostheses, Steel 1.4034 or Steel 1.4037, 43mm x 22mm x 0.1mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
11e87fc6-f458-4e64-8a0c-446136d9b162
Distribution Status:
In Commercial Distribution
DUNS Number:
341155720
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
14250368861406
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 60394
Name: ENT cartilage cutter blade
Definition:
A sterile, sharp metal blade intended to be mounted onto an ENT cartilage cutter to cut thin slices of harvested cartilage tissue (e.g., tragus-derived autograft) for patient implantation during an ear/nose/throat (ENT) procedure (e.g., middle ear surgery). This is a single-use device.
FDA Product Codes
GES
Blade, Scalpel