Device
3M™ Unitek™ Lingual Sheaths, 080-251P, UL/LR, Horizontal, Slotted, .036,
Manufacturer
3M UNITEK CORPORATION
Model: 080-251P Catalog: 080-251P DI: 00652221303028 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-04-25 Current Version: 2026-05-04
Description
3M™ Unitek™ Lingual Sheaths, 080-251P, UL/LR, Horizontal, Slotted, .036, Hk, Latch, 5/Pk
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 4edb9894-162a-46f8-b7dd-21f2883bdef8
Distribution Status: In Commercial Distribution
DUNS Number: 008256356
Device Count: 5
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: 80652221303024
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00652221303028
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 38734
Name: Orthodontic metal band
Definition:
A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
DYO
BAND, MATERIAL, ORTHODONTIC