FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC

DI: 00840018637009 · Model: REBR3T-CHP2T · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC
Primary DI
00840018637009
Version / Model
REBR3T-CHP2T
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-27
Public Version
1
Public Version Date
2020-06-04
Public Version Status
New
Public Device Record Key
ef5e0a2c-9596-4b53-a28a-27cb3a4cff54

Device Description

BURNESHER #3, PLACEMENT INST #

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
EKJ Burnisher, Operative

GMDN Terms

Code Name
64078 Manual dental burnisher, reusable

Identifiers

Type ID
Primary 00840018637009