FDA UDI In Commercial Distribution 🇺🇸 United States

First Molar Double Tubes

DI: 00192029026670 · Model: 391-221 · TP ORTHODONTICS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
First Molar Double Tubes
Primary DI
00192029026670
Version / Model
391-221
Company Name
TP ORTHODONTICS INC
Labeler DUNS
005432299
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-03-15
Public Version
1
Public Version Date
2021-03-23
Public Version Status
New
Public Device Record Key
7108155e-1e98-4100-bcc2-a5cc1c5a7178

Device Description

UP/LO 1st Molar NO HK Torque 0, Tip 0, Distal Offset 0 0.46 mm x 0.64mm (.018" x .025") 4.5 mm

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DZD TUBE, ORTHODONTIC

GMDN Terms

Code Name
31759 Orthodontic tube

Identifiers

Type ID
Primary 00192029026670