KOMET Root Canal Files PRQ6L21.204.020

GUDID E226100105588

Gebr. Brasseler GmbH & Co. KG

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: E226100105588
• NIH Device Record Key: bb414c73-2c8a-416a-af83-d6d46bee86f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET Root Canal Files
• Version Model Number: PRQ6L21.204.020.G1
• Catalog Number: PRQ6L21.204.020
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E226100105581 [Primary]
HIBCC	E226100105588 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [KOMET Root Canal Files]

• E226100106048: PRQ4L31.204.050.G1
• E226100106028: PRQ4L31.204.045.G1
• E226100106008: PRQ5L31.204.040.G1
• E226100105988: PRQ5L31.204.035.G1
• E226100105968: PRQ6L31.204.030.G1
• E226100105948: PRQ6L31.204.025.G1
• E226100105928: PRQ6L31.204.020.G1
• E226100105908: PRQ4L25.204.050.G1
• E226100105888: PRQ4L25.204.045.G1
• E226100105868: PRQ5L25.204.040.G1
• E226100105848: PRQ5L25.204.035.G1
• E226100105828: PRQ6L25.204.030.G1
• E226100105808: PRQ6L25.204.025.G1
• E226100105788: PRQ6L25.204.020.G1
• E226100105768: PRQ4L21.204.050.G1
• E226100105738: PRQ4L21.204.045.G1
• E226100105688: PRQ5L21.204.040.G1
• E226100105648: PRQ5L21.204.035.G1
• E226100105628: PRQ6L21.204.030.G1
• E226100105608: PRQ6L21.204.025.G1
• E226100105588: PRQ6L21.204.020.G1
• E226100090778: RE05L25.204.025.G1
• E226100090768: RE05L21.204.025.G1
• E226100090758: RE10L15.204.030.G1
• E226100027348: OPR08L19.204.025.G1
• E226048921G18: OP10L15.204.030.G1
• E226048579G18: PG03L31.204.020.G1
• E226048578G18: PG03L31.204.015.G1
• E226048435G18: OP08L19.204.025.G1
• E226047492G18: PG03L21.204.020.G1
• E226047491G18: PG03L21.204.015.G1
• E226046911G18: OP10L19.204.030.G1
• E226046838G18: PG03L25.204.020.G1
• E226046802G18: F06L31.204.035.G1
• E226046801G18: F06L25.204.035.G1
• E226046800G18: F06L21.204.035.G1
• E226046720G18: F06L31.204.040.G1
• E226046719G18: F06L31.204.030.G1
• E226046718G18: F06L31.204.025.G1
• E226046717G18: F06L31.204.020.G1
• E226046716G18: F06L25.204.040.G1
• E226046715G18: F06L25.204.030.G1
• E226046714G18: F06L25.204.025.G1
• E226046713G18: F06L25.204.020.G1
• E226046712G18: F06L21.204.040.G1
• E226046711G18: F06L21.204.030.G1
• E226046710G18: F06L21.204.025.G1
• E226046709G18: F06L21.204.020.G1
• E226045001G18: PG03L25.204.015.G1
• E226044151G18: F04L31.204.055.G1