FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC

DI: 00840018638914 · Model: EOTN119 · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC
Primary DI
00840018638914
Version / Model
EOTN119
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-06-09
Public Version
1
Public Version Date
2020-06-17
Public Version Status
New
Public Device Record Key
d65b51c2-3b9a-4aea-8ffa-655f7c7517ac

Device Description

ORTHO SCLR-BD STR DE #119 DL-H

Device Characteristics

Single Use
No
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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
["Dry Heat Sterilization", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
ECR Setter, Band, Orthodontic

GMDN Terms

Code Name
31801 Orthodontic metal band pusher

Identifiers

Type ID
Primary 00840018638914