FDA UDI In Commercial Distribution 🇺🇸 United States

Endodontic Hand Instruments

DI: D71626325451 · Model: 2632545 · TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6

Basic Information

Brand Name
Endodontic Hand Instruments
Primary DI
D71626325451
Version / Model
2632545
Catalog Number
2632545
Company Name
TULSA DENTAL PRODUCTS LLC
Labeler DUNS
942778564
Distribution Status
In Commercial Distribution
Device Count in Pkg
6
Record Status
Published
Publish Date
2022-11-19
Public Version
1
Public Version Date
2022-11-28
Public Version Status
New
Public Device Record Key
5d2744c3-26cd-4466-9fe5-20b7b430e163

Device Description

NI-TI K-FILES 25MM 45 R

Device Characteristics

Single Use
Yes
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
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
EKS FILE, PULP CANAL, ENDODONTIC

GMDN Terms

Code Name
63720 Manual endodontic file/rasp, single-use

Identifiers

Type ID
Unit of Use D71626325450
Primary D71626325451