FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC.

DI: 00840018658394 · Model: REC3 · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC.
Primary DI
00840018658394
Version / Model
REC3
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-04-20
Public Version
1
Public Version Date
2021-04-28
Public Version Status
New
Public Device Record Key
c06468ae-4786-4356-bb9c-c5c8545082e7

Device Description

Excavator, DE, Spoon #3 (2.0 mm Head Size #19), Medium Round Handle

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
EKC Excavator, Dental, Operative

GMDN Terms

Code Name
35811 Dental excavator, reusable

Identifiers

Type ID
Primary 00840018658394