FDA UDI In Commercial Distribution 🇺🇸 United States

TRIPLE-TWIST™

DI: 00810042122161 · Model: 0235-I · ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TRIPLE-TWIST™
Primary DI
00810042122161
Version / Model
0235-I
Company Name
ORTHODONTIC SUPPLY & EQUIPMENT COMPANY INC
Labeler DUNS
077801124
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-01
Public Version
1
Public Version Date
2020-06-09
Public Version Status
New
Public Device Record Key
4a323402-4166-4cf4-aee2-c885f4e00842

Device Description

3 Strand Twisted Stainless Steel Archwires Standard Form .0195

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
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
DZC Wire, Orthodontic

GMDN Terms

Code Name
41397 Orthodontic archwire

Identifiers

Type ID
Primary 00810042122161