FDA.reportPublic FDA data

Mathieu Needle Holder

Primary DI
G443CSC2121
Brand
Mathieu Needle Holder
Company
CHURAHI SURGICAL CO.
Model
CSC-212
Catalog number
CSC-212
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
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G443CSC2121PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
G443CSC2011Ligature director and tuckerCSC-201CSC-2012023-08-08
G443CSC2031Double-Ended Distal End BenderCSC-203CSC-2032023-08-08
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
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09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
04052536078264uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078271uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078295uCentumUlrich GmbH & Co. KGHXK2025-08-01
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