Device
Tray Tympanoplasty Prostheses, Steel 1.4301 / 1.4305 / Silicon, length: 177mm, width: 89mm, hight: 36mm
Manufacturer
Heinz Kurz GmbH
Heinz Kurz GmbH
Model: 8000176
Catalog: 8000176
DI: 14250368861765
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
Tray Tympanoplasty Prostheses, Steel 1.4301 / 1.4305 / Silicon, length: 177mm, width: 89mm, hight: 36mm
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:
0c8236e7-487c-4784-bd85-7b182ed591e6
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:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
14250368861765
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 42997
Name: Surgical instrument/implant rack
Definition:
A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.
FDA Product Codes
MMO
Tray, Surgical, Ent