FDA UDI In Commercial Distribution 🇺🇸 United States

Tanzo

DI: 00190746014253 · Model: 827-1U-14PSW · AMERICAN ORTHODONTICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Tanzo
Primary DI
00190746014253
Version / Model
827-1U-14PSW
Catalog Number
827-1U-14PSW
Company Name
AMERICAN ORTHODONTICS CORPORATION
Labeler DUNS
044668515
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-11-24
Public Version
5
Public Version Date
2023-11-20
Public Version Status
Update
Public Device Record Key
73f7a634-f699-4d06-8aa2-87f72455ab6d

Device Description

WIRE TANZO MID FORM I UPPER 014 W/PRE-LOADED STOPS IND 10/PK

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DZC WIRE, ORTHODONTIC

GMDN Terms

Code Name
16204 Orthodontic wire

Identifiers

Type ID
Primary 00190746014253

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
High: 38 Degrees Celsius
Type
Storage Environment Humidity
Temperature Range
0 – 60 Percent (%) Relative Humidity