Device
Instrument Tympanoplasty Prostheses, Steel 1.4021, length: 69mm, width: 14mm
Manufacturer
Heinz Kurz GmbH
Model: 8000200 Catalog: 8000200 DI: 14250368862007 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, Steel 1.4021, length: 69mm, width: 14mm
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: 5ba54b92-b234-4830-abc2-ff542675904c
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: 14250368862007
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
LRC
Instrument, Ent Manual Surgical