FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC

DI: 00840018657281 · Model: ENSNMJ · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC
Primary DI
00840018657281
Version / Model
ENSNMJ
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-21
Public Version
1
Public Version Date
2020-10-29
Public Version Status
New
Public Device Record Key
c98a91ba-de0e-4769-8e50-c608f4be02c7

Device Description

XDURA SCALER, DE, OFFSET SICKLE NMJ UNIVERSAL R138, HEX 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
ELA Instrument, Hand, Calculus Removal

GMDN Terms

Code Name
35320 Manual dental scaler, reusable

Identifiers

Type ID
Primary 00840018657281