KOMET Root Canal Files F06L31.204.035

GUDID E226046802G18

Gebr. Brasseler GmbH & Co. KG

Rotary/reciprocating endodontic file/rasp, single-use
Primary Device IDE226046802G18
NIH Device Record Key474f0df7-4ec2-4c3e-9eb9-0787dcceec9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKOMET Root Canal Files
Version Model NumberF06L31.204.035.G1
Catalog NumberF06L31.204.035
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
HIBCCE226046802G11 [Primary]
HIBCCE226046802G18 [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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