FDA UDI In Commercial Distribution 🇺🇸 United States

NTI

DI: E310FS2M1 · Model: FS2-M · NTI - Kahla GmbH Rotary Dental Instruments
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
NTI
Primary DI
E310FS2M1
Version / Model
FS2-M
Catalog Number
FS2-M
Company Name
NTI - Kahla GmbH Rotary Dental Instruments
Labeler DUNS
314810326
Distribution Status
In Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2022-01-01
Public Version
1
Public Version Date
2022-01-10
Public Version Status
New
Public Device Record Key
b0cd6907-f33f-4d42-a6bd-ce4f52971247

Device Description

NTI Diamond Strip 2.5mm - M

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
Yes
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
Moist Heat or Steam Sterilization

Product Codes

Code Name
DZP INSTRUMENT, DIAMOND, DENTAL

GMDN Terms

Code Name
63358 Dental abrasive strip, reusable

Identifiers

Type ID
Unit of Use E310FS2M0
Primary E310FS2M1