Device
Instrument Tympanoplasty Prostheses, Titanium, length: 153mm
Manufacturer
Heinz Kurz GmbH
Heinz Kurz GmbH
Model: 8000137
Catalog: 8000137
DI: 14250368861376
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Instrument Tympanoplasty Prostheses, Titanium, length: 153mm
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a563f4fb-f884-4a9b-8149-df72af2e827d
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:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
14250368861376
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44067
Name: ENT surgical procedure kit, non-medicated, reusable
Definition:
A 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.
FDA Product Codes
NNS
Instrument, Prosthesis Modification For Ossicular Replacement Surgery, Non-Sterile