Device
4581-3175 UNITEK LATERAL DEVT ARCHWIRE NITINOL 020 W/STOP R26
Manufacturer
3M UNITEK CORPORATION
3M UNITEK CORPORATION
Model: 4581-3175
Catalog: 4581-3175
DI: 00652221167309
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
4581-3175 UNITEK LATERAL DEVT ARCHWIRE NITINOL 020 W/STOP R26
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
21ec98e8-2f59-4a9f-9365-0563c0102106
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:
80652221167305
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00652221167309
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 41397
Name: Orthodontic archwire
Definition:
A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
DZC
WIRE, ORTHODONTIC