Model: Martensitic positioner
Catalog: 16-261
DI: 08961104622159
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
polar bear Martensitic positioner
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c733f04e-3203-4205-af07-cea8d5d8291f
Distribution Status:
In Commercial Distribution
DUNS Number:
645674404
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:
Yes
Identifiers
Device ID:
08961104622159
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 37413
Name: Orthodontic ligature director
Definition:
A hand-held dental instrument used to tuck and direct ligatures under the archwire or bracket wings or to push archwires or auxiliaries into position. This is a reusable device.
FDA Product Codes
DZN
Instruments, Dental Hand