FDA.reportPublic FDA data

KINCISE™ System Acetabular Cup Extraction Wrench

Primary DI
08720254007038
Brand
KINCISE™ System Acetabular Cup Extraction Wrench
Company
Spierings Orthopaedics B.V.
Model
KIN-2110-02
Catalog number
200005017
Published
2024-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720254007038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720254007038087202540070388720254007038

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
407288690
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
08720828234181KINCISE™ System Acetabular Cup Extraction Case Standard SetKIN-2110-062000051002024-03-26
08720828234198KINCISE™ System Acetabular Cup Extraction Case Outlier SetKIN-2110-072000052002024-03-26
08720254007472KINCISE™ System Acetabular Cup Extraction Finisher Blade 44mmKIN-2110-44F-SU2000052442024-03-20
08720254007489KINCISE™ System Acetabular Cup Extraction Finisher Blade 46mmKIN-2110-46F-SU2000052462024-03-20
08720254007496KINCISE™ System Acetabular Cup Extraction Finisher Blade 48mmKIN-2110-48F-SU2000052482024-03-20
08720254007502KINCISE™ System Acetabular Cup Extraction Finisher Blade 50mmKIN-2110-50F-SU2000052502024-03-20
08720254007519KINCISE™ System Acetabular Cup Extraction Finisher Blade 52mmKIN-2110-52F-SU2000052522024-03-20
08720254007526KINCISE™ System Acetabular Cup Extraction Finisher Blade 54mmKIN-2110-54F-SU2000052542024-03-20
08720254007533KINCISE™ System Acetabular Cup Extraction Finisher Blade 56mmKIN-2110-56F-SU2000052562024-03-20
08720254007540KINCISE™ System Acetabular Cup Extraction Finisher Blade 58mmKIN-2110-58F-SU2000052582024-03-20
08720254007557KINCISE™ System Acetabular Cup Extraction Finisher Blade 60mmKIN-2110-60F-SU2000052602024-03-20
08720254007564KINCISE™ System Acetabular Cup Extraction Finisher Blade 62mmKIN-2110-62F-SU2000052622024-03-20
08720254007571KINCISE™ System Acetabular Cup Extraction Finisher Blade 64mmKIN-2110-64F-SU2000052642024-03-20
08720254007588KINCISE™ System Acetabular Cup Extraction Finisher Blade 66mmKIN-2110-66F-SU2000052662024-03-20
08720254007595KINCISE™ System Acetabular Cup Extraction Finisher Blade 68mmKIN-2110-68F-SU2000052682024-03-20
08720254007007KINCISE™ System Acetabular Cup Extraction ShaftKIN-2110-012000050002024-03-19
08720254007014KINCISE™ System Acetabular Cup Extraction BoltKIN-2110-042000050152024-03-19
08720254007021KINCISE™ System Acetabular Cup Extraction Hex KeyKIN-2110-052000050162024-03-19
08720254007069KINCISE™ System Acetabular Cup Extraction SST Head 26mmKIN-2110-26-SS2000050262024-03-19
08720254007076KINCISE™ System Acetabular Cup Extraction SST Head 28mmKIN-2110-28-SS2000050282024-03-19

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