KINCISE 200000101

GUDID 07612334260079

KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE

Synthes GmbH

Device sterilization/disinfection container, reusable

• Primary Device ID: 07612334260079
• NIH Device Record Key: ee3b86e4-684b-4e4c-9cca-4246814ccaf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KINCISE
• Version Model Number: 2000-00-101
• Catalog Number: 200000101
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334260079 [Direct Marking]
GS1	10886982348111 [Primary]

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-08
• Device Publish Date: 2024-10-31

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• 07612334268792: EMPHASYS™ KINCISE™ System Stem Impactor - Straight
• 07612334268785: EMPHASYS™ KINCISE™ System Straight Shell/Liner Impactor - Short
• 07612334268778: EMPHASYS™ KINCISE™ System Offset Shell/Liner Impactor
• 07612334268761: EMPHASYS™ KINCISE™ SYSTEM Straight Shell/Liner Impactor - Long
• 07612334268754: KINCISE™ System Primary Hip Femoral Head Impactor - Shaft
• 07612334268747: KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Straight
• 07612334268730: KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ SUMMIT™ Stem Impactor- Straight
• 07612334268723: KINCISE™ System Primary Hip ACTIS™ Stem Impactor - Offset
• 07612334268716: KINCISE™ System Primary Hip CORAIL™ TRI-LOCK™ Stem Impactor - Offset
• 07612334268693: KINCISE™ System Primary Hip Femoral Broach Adapter - Straight
• 07612334268686: KINCISE™ System Primary Hip Femoral Broach Adapter - Curved
• 07612334268655: KINCISE™ System Manual Handle
• 07612334268648: KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Short
• 07612334268631: KINCISE™ System Primary Hip, Screwdriver, hexagonal, 8.0mm
• 07612334268624: KINCISE™ System Primary Hip PINNACLE™ Version Guide
• 07612334268617: KINCISE™ System Primary Hip PINNACLE™ Inclination Guide
• 07612334268600: KINCISE™ System Primary Hip PINNACLE™ Offset Shell/Liner Impactor
• 07612334268594: KINCISE™ System Primary Hip PINNACLE™ Straight Shell/Liner Impactor - Long
• 07612334268570: KINCISE™ System Lithium-ion Battery
• 07612334268563: KINCISE™ System Automated Surgical Handpiece V2
• 07612334268679: KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
• 07612334268587: KINCISE(TM) SYSTEM STERILIZATION CASE LID
• 07612334260079: KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE