Device
Roller Knife, SCHUKNECHT, 16CM, In-Line Blade
Manufacturer
ELMED INCORPORATED
Model: 45701-01 Catalog: 45701-01 DI: 00198506090394 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-30 Current Version: 2026-05-08
Description
Roller Knife, SCHUKNECHT, 16CM, In-Line Blade
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: 101850ae-bdc7-4b97-ab8b-6d6460368fb0
Distribution Status: In Commercial Distribution
DUNS Number: 049290364
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
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: 00198506090394
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