FDA UDI In Commercial Distribution 🇺🇸 United States

NORDENT MANUFACTURING INC

DI: 00840018615328 · Model: RESCGR11-12J-N · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NORDENT MANUFACTURING INC
Primary DI
00840018615328
Version / Model
RESCGR11-12J-N
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-07
Public Version
1
Public Version Date
2020-08-17
Public Version Status
New
Public Device Record Key
91323517-b1f1-4fa7-bdd8-f431b8be98d4

Device Description

SCALER, DOUBLE END, GRACEY #11-12 J-BLADE NAKAGAWA, DURALITE 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
Yes
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 00840018615328