Device
Instrument Tympanoplasty Prostheses, Polypropylene, 49.5mm x 44.0mm x 5.00mm
Manufacturer
Heinz Kurz GmbH
Heinz Kurz GmbH
Model: 8000540
Catalog: 8000540
DI: 14250368865404
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, Polypropylene, 49.5mm x 44.0mm x 5.00mm
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3b977fd5-3fe3-49ec-bfe8-a2d8174b519d
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:
14250368865404
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 61246
Name: Surgical implant/trial-implant/sizer holder, single-use
Definition:
A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a single-use device.
FDA Product Codes
JYJ
Gauge, Measuring