Device
TBS BASICS Orthodontic Direct Bond Bracket Holder, Curved
Manufacturer
ACME ENTERPRISE.
ACME ENTERPRISE.
Model: TBSB125
Catalog: TBSB125
DI: G149TBSB1250
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
TBS BASICS Orthodontic Direct Bond Bracket Holder, Curved
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:
2c82fde0-fb11-4504-a1fa-dd937c59db2e
Distribution Status:
In Commercial Distribution
DUNS Number:
645459892
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:
No
Identifiers
Device ID:
G149TBSB1250
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 42500
Name: Dressing/utility forceps, tweezers-like, reusable
Definition:
A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. This is a reusable device intended to be sterilized prior to use.
FDA Product Codes
ECQ
Aligner, Bracket, Orthodontic