FDA UDI In Commercial Distribution 🇺🇸 United States

BURKHART DENTAL

DI: 00840018604261 · Model: S204S/6BH · NORDENT MANUFACTURING INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
BURKHART DENTAL
Primary DI
00840018604261
Version / Model
S204S/6BH
Company Name
NORDENT MANUFACTURING INC
Labeler DUNS
053187985
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-21
Public Version
1
Public Version Date
2020-05-29
Public Version Status
New
Public Device Record Key
aad451c3-5972-4a42-8e0b-48e9dd264188

Device Description

BDS SCALER DE POSTERIOR SICKLE #204S #6

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 00840018604261