Device
3M™ Unitek™ Gurin Nut, 561-100, For Archwire .014/.016 in, 1/Pk
Manufacturer
3M UNITEK CORPORATION
3M UNITEK CORPORATION
Model: 561--100
Catalog: 561--100
DI: 00652221099204
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
3M™ Unitek™ Gurin Nut, 561-100, For Archwire .014/.016 in, 1/Pk
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eab3971f-1412-4d56-8175-fcbc1425c671
Distribution Status:
In Commercial Distribution
DUNS Number:
008256356
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:
00652221099204
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35310
Name: Orthodontic retainer
Definition:
An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.
FDA Product Codes
DZC
WIRE, ORTHODONTIC