KyphoPak™ Express™ Tray

GUDID 00643169100695

KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00643169100695
• NIH Device Record Key: 98e5ecc9-6dfa-4b0e-acfb-b626409b6793
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KyphoPak™ Express™ Tray
• Version Model Number: KPE1003
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169100695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041454

FDA Product Code

• HRX: ARTHROSCOPE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-16

On-Brand Devices [KyphoPak™ Express™ Tray]

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• 00613994721297: KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
• 00613994721280: KIT KPE1002 KYPAK EXPRESS TRAY 10/2 AF
• 00613994721273: KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS
• 00613994671790: CementSys KPE1003-CDS FF Express 15/2
• 00613994579805: CementSys KPE1001-CDS FF Express 10/2
• 00643169103122: KIT KPE1004 KYPAK EXP TRY 15/2 AF
• 00643169103115: KIT KPE1002 KYPAK EXP TRY 10/2 AF
• 00643169103108: KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS
• 00643169100701: CEMENTSYS KPE1001-CDS FF EXPRESS 10/2
• 00643169100695: KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
• 00643169100688: CEMENTSYS KPE1003-CDS FF EXPRESS 15/2
• 00643169456013: CEMENTSYS KPE1003-CDS FF EXPRESS 15/2
• 00643169456006: CEMENTSYS KPE1001-CDS FF EXPRESS 10/2
• 00858196001352: KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS