Reciproc Rotary Files TSTRCP0621040

GUDID D716TSTRCP06210400

RECIPROC R40 21mm

TULSA DENTAL PRODUCTS LLC

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDD716TSTRCP06210400
NIH Device Record Key608d246e-a81d-45ea-9b1b-e5b996b115f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameReciproc Rotary Files
Version Model NumberTSTRCP0621040
Catalog NumberTSTRCP0621040
Company DUNS942778564
Company NameTULSA DENTAL PRODUCTS LLC
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD716TSTRCP06210400 [Unit of Use]
HIBCCD716TSTRCP06210401 [Primary]

FDA Product Code

EKSFILE, PULP CANAL, ENDODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-02
Device Publish Date2024-03-25

On-Brand Devices [Reciproc Rotary Files]

D716TSTRCP06310500RECIPROC R50 31mm
D716TSTRCP06310400RECIPROC R40 31mm
D716TSTRCP06310250RECIPROC R25 31mm
D716TSTRCP0625AST0RECIPROC Assortment 25mm
D716TSTRCP06250500RECIPROC R50 25mm
D716TSTRCP06250400RECIPROC R40 25mm
D716TSTRCP06250250RECIPROC R25 25mm
D716TSTRCP0621AST0RECIPROC Assortment 21mm
D716TSTRCP06210500RECIPROC R50 21mm
D716TSTRCP06210400RECIPROC R40 21mm
D716TSTRCP06210250RECIPROC R25 21mm
D716TSTRCP03310500RECIPROC R50 31mm
D716TSTRCP03310400RECIPROC R40 31mm
D716TSTRCP03310250RECIPROC R25 31mm
D716TSTRCP0325AST0RECIPROC Assortment 25mm
D716TSTRCP03250500RECIPROC R50 25mm
D716TSTRCP03250400RECIPROC R40 25mm
D716TSTRCP03250250RECIPROC R25 25mm
D716TSTRCP0321AST0RECIPROC Assortment 31mm
D716TSTRCP03210500RECIPROC R50 21mm
D716TSTRCP03210400RECIPROC R40 21mm
D716TSTRCP03210250RECIPROC R25 21mm

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