Device
Instrument Tympanoplasty Prostheses, Polypropylene, 49.5mm x 44.0mm x 5.00mm
Manufacturer
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