Aligner Tear Drop Plier CSC300AT

GUDID G443CSC300AT0

Orthodontic Pliers are positive locking plier intended for holding, placing, and tying ligatures and elastics. They also can be used for grasping and guiding a needle when suturing.

CHURAHI SURGICAL CO.

Orthodontic pliers
Primary Device IDG443CSC300AT0
NIH Device Record Keyc63ee626-695c-4ff2-b3b4-22eff51221f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAligner Tear Drop Plier
Version Model NumberCSC300AT
Catalog NumberCSC300AT
Company DUNS645513524
Company NameCHURAHI SURGICAL CO.
Device Count1
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG443CSC300AT0 [Primary]

FDA Product Code

JEXPlier, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


[G443CSC300AT0]

Ethylene Oxide;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-12
Device Publish Date2023-06-03

Devices Manufactured by CHURAHI SURGICAL CO.

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G443CSC2311 - Bracket Tweezer with Slot2023-08-16
G443CSC2321 - Bracket Tweezer Tube Holding2023-08-16
G443CSC2331 - Bracket Tweezer small Point2023-08-16
G443CSC1021 - Weingart Universal Plier2023-08-15

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