29445SHA

GUDID H67929445SHA0

4.0MM SCHANZ SCREW SPADE POINT 100MM/HA COATING-STERILE

Synthes GmbH

External orthopaedic fixation system, reusable

• Primary Device ID: H67929445SHA0
• NIH Device Record Key: c6bb8dd0-2fcd-4b71-ba92-af7842d6b23a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 294.45SHA
• Catalog Number: 29445SHA
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982181442 [Primary]
HIBCC	H67929445SHA0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040701

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-27
• Device Publish Date: 2015-09-14

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• 07612334268617 - KINCISE: 2024-11-04 KINCISE™ System Primary Hip PINNACLE™ Inclination Guide