Device
3M™ Unitek™ MIA Mobile Interarch System Curved Lingual Sheath, 340-017,
Manufacturer
3M UNITEK CORPORATION
Model: 340--017 Catalog: 340--017 DI: 00652221071316 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™ MIA Mobile Interarch System Curved Lingual Sheath, 340-017, .036 in. 10/Pk
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 5d38567c-f975-4b9f-badb-1682d371f54b
Distribution Status: In Commercial Distribution
DUNS Number: 008256356
Device Count: 10
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
Item #1 - Device ID: 80652221071312
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00652221071316
Item #2 - Device ID Type: Primary
Item #2 - Device ID 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