FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC

DI: 00840018632813 · Model: REENDRG21-25 · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC
Primary DI
00840018632813
Version / Model
REENDRG21-25
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
2
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
9192db1a-6c73-45d2-ae75-41568f11b4f6

Device Description

ROOT CANAL SPREADER, DE, #D11T

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
EKK Spreader, Pulp Canal Filling Material, Endodontic

GMDN Terms

Code Name
37678 Manual endodontic filling material spreader

Identifiers

Type ID
Primary 00840018632813