Device
50-0300-0000
Manufacturer
Gc Orthodontics America Inc.
Model: 50-0300-0000 Catalog: 50-0300-0000 DI: 10840539702450 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-28 Current Version: 2026-06-05
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: ae305e6e-6373-47ec-b968-e4f1c48b962d
Distribution Status: In Commercial Distribution
DUNS Number: 063167128
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: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 10840539702450
Type: Primary
Issuing Agency: GS1
GMDN
Code: 33209
Name: Orthodontic pliers
Definition:
A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.
FDA Product Codes
JEX
PLIER, ORTHODONTIC