FDA UDI In Commercial Distribution 🇺🇸 United States

Endodontic Hand Instruments

DI: D716873211601 · Model: 87321160 · 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
D716873211601
Version / Model
87321160
Catalog Number
87321160
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
ad7dc5a1-0a8e-4611-a6e1-0f1844285f01

Device Description

Hedstroem 21/15-40 Exp

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 D716873211600
Primary D716873211601