KOMET Root Canal Files PRQ4L25.204.045

GUDID E226100105888

Gebr. Brasseler GmbH & Co. KG

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDE226100105888
NIH Device Record Key48ce57e7-792d-49a1-8470-d77d19dcff4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET Root Canal Files
Version Model NumberPRQ4L25.204.045.G1
Catalog NumberPRQ4L25.204.045
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
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 Datetrue
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
HIBCCE226100105881 [Primary]
HIBCCE226100105888 [Unit of Use]

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 Date2023-02-09
Device Publish Date2023-02-01

On-Brand Devices [KOMET Root Canal Files]

E226100106048PRQ4L31.204.050.G1
E226100106028PRQ4L31.204.045.G1
E226100106008PRQ5L31.204.040.G1
E226100105988PRQ5L31.204.035.G1
E226100105968PRQ6L31.204.030.G1
E226100105948PRQ6L31.204.025.G1
E226100105928PRQ6L31.204.020.G1
E226100105908PRQ4L25.204.050.G1
E226100105888PRQ4L25.204.045.G1
E226100105868PRQ5L25.204.040.G1
E226100105848PRQ5L25.204.035.G1
E226100105828PRQ6L25.204.030.G1
E226100105808PRQ6L25.204.025.G1
E226100105788PRQ6L25.204.020.G1
E226100105768PRQ4L21.204.050.G1
E226100105738PRQ4L21.204.045.G1
E226100105688PRQ5L21.204.040.G1
E226100105648PRQ5L21.204.035.G1
E226100105628PRQ6L21.204.030.G1
E226100105608PRQ6L21.204.025.G1
E226100105588PRQ6L21.204.020.G1
E226100090778RE05L25.204.025.G1
E226100090768RE05L21.204.025.G1
E226100090758RE10L15.204.030.G1
E226100027348OPR08L19.204.025.G1
E226048921G18OP10L15.204.030.G1
E226048579G18PG03L31.204.020.G1
E226048578G18PG03L31.204.015.G1
E226048435G18OP08L19.204.025.G1
E226047492G18PG03L21.204.020.G1
E226047491G18PG03L21.204.015.G1
E226046911G18OP10L19.204.030.G1
E226046838G18PG03L25.204.020.G1
E226046802G18F06L31.204.035.G1
E226046801G18F06L25.204.035.G1
E226046800G18F06L21.204.035.G1
E226046720G18F06L31.204.040.G1
E226046719G18F06L31.204.030.G1
E226046718G18F06L31.204.025.G1
E226046717G18F06L31.204.020.G1
E226046716G18F06L25.204.040.G1
E226046715G18F06L25.204.030.G1
E226046714G18F06L25.204.025.G1
E226046713G18F06L25.204.020.G1
E226046712G18F06L21.204.040.G1
E226046711G18F06L21.204.030.G1
E226046710G18F06L21.204.025.G1
E226046709G18F06L21.204.020.G1
E226045001G18PG03L25.204.015.G1
E226044151G18F04L31.204.055.G1

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