FDA.reportPublic FDA data

KINCISE™ System Acetabular Cup Extraction Case Outlier Set

Primary DI
08720828234198
Brand
KINCISE™ System Acetabular Cup Extraction Case Outlier Set
Company
Spierings Orthopaedics B.V.
Model
KIN-2110-07
Catalog number
200005200
Published
2024-03-26
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
08720828234198PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720828234198087208282341988720828234198

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. 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
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
08720254007038KINCISE™ System Acetabular Cup Extraction WrenchKIN-2110-022000050172024-03-19
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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