FDA.reportPublic FDA data

Ligature director and tucker

Primary DI
G443CSC2011
Brand
Ligature director and tucker
Company
CHURAHI SURGICAL CO.
Model
CSC-201
Catalog number
CSC-201
Published
2023-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G443CSC2011PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual dental scaler, reusableA hand-held dental instrument designed for removing calculus and other accretions from the surface and between the teeth during dental cleaning and periodontal (gum) therapy. It is typically designed as a one-piece instrument with a pointed, distal end of various shapes and sizes. Also known as a periodontic scaler, it can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645513524
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G443CSC2031Double-Ended Distal End BenderCSC-203CSC-2032023-08-08
G443CSC2121Mathieu Needle HolderCSC-212CSC-2122023-08-08
G443CSC2201MBT Bracket Height GaugeCSC-220CSC-2202023-08-08
G443CSC2311Bracket Tweezer with SlotCSC-231CSC-2312023-08-08
G443CSC2321Bracket Tweezer Tube HoldingCSC-232CSC-2322023-08-08
G443CSC2331Bracket Tweezer small PointCSC-233CSC-2332023-08-08
G443CSC1021Weingart Universal PlierCSC-102CSC-1022023-08-07
G443CSC1031Lingual Weingart PlierCSC-103CSC-1032023-08-07
G443CSC1121Distal end CutterCSC-112CSC-1122023-08-07
G443CSC1131Distal end Flush CutterCSC-113CSC-1132023-08-07
G443CSC1211Pin & Ligature CutterCSC-121CSC-1212023-08-07
G443CSC1311Bracket Remover Straight PlierCSC-131CSC-1312023-08-07
G443CSC1601Hammer Head PlierCSC-160CSC-1602023-08-07
G443CSC184000Tischler Biopsy ForcepCSC18400CSC184002023-06-06
G443CSC184010Baby Tischler ForcepCSC18401CSC184012023-06-06
G443CSC301AT0Aligner Horizontal PlierCSC301ATCSC301AT2023-06-05
G443CSC302AT0Aligner Vertical PlierCSC302ATCSC302AT2023-06-05
G443CSC303AT0Aligner Hole Punch PlierCSC303ATCSC303AT2023-06-05
G443CSC304AT0Aligner Retention PlierCSC304ATCSC304AT2023-06-05
G443CSC300AT0Aligner Tear Drop PlierCSC300ATCSC300AT2023-06-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5190TBS BASICSACME ENTERPRISE.EMN2026-05-20
EZPF2423804S0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
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EZPF2423823A0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2026-04-13
08800075614841OSUNG MNDOSUNG MND Co., Ltd.EMN2025-11-03
07898506810871QuinelatoSchobell Industrial LtdaEMN2023-01-09
07898506810888QuinelatoSchobell Industrial LtdaEMN2023-01-09
EZPFKS242880HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEMN2022-12-16
08800000981444Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981451Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
08800000981468Metal ScalerOsstem Implant Co., Ltd.EMN2022-12-08
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