KyphoPak™ Tray

GUDID 00613994579829

CementSys KPT1005-CDS FF XPDR 10/3 1 Stp

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00613994579829
• NIH Device Record Key: 5981796f-ebce-42a6-ad6d-13bb9f11c2ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KyphoPak™ Tray
• Version Model Number: KPT1005-CDS
• 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	00613994579829 [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: 2016-07-16

On-Brand Devices [KyphoPak™ Tray]

• 00613994750549: KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
• 00613994703972: KIT KPT1502 PAKTRAY 15/3 FF W/OIS-RB
• 00613994703965: KIT KPT1505 PAKTRY 15/3 FF W/ONESTEP-RB
• 00613994703941: KIT KPT2005 PAKTRY 20/3 FF W/ONE STEP-RB
• 00613994671721: CementSys KPT1505-CDS FF XPDR 15/3 1 Stp
• 00613994668738: KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS
• 00613994579843: CementSys KPT2005-CDS FF XPDR 20/3 1 Stp
• 00613994579836: CementSys KPT1505-CDS FF XPDR 15/3 1 Stp
• 00613994579829: CementSys KPT1005-CDS FF XPDR 10/3 1 Stp
• 00643169103139: KIT KPT1003 KYPAK TRY 10/3 FF W/ADV OIS
• 00643169102989: KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP
• 00643169102972: KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE
• 00643169102965: KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS
• 00643169102958: KIT KPT2002 KYPAK TRY 20/3 FF W/OIS
• 00643169102941: KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP
• 00643169102934: KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
• 00643169102927: KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS
• 00643169102910: KIT KPT1502 KYPAK TRY 15/3 FF W/OIS
• 00643169102903: KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE
• 00643169100671: KIT KPT1001 KYPHOPAK TRAY 10/3 FF W/ITK
• 00643169100664: KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS
• 00643169100657: CEMENTSYS KPT1002-CDS OIS XPDR 10/3
• 00643169100640: CEMENTSYS KPT1003-CDS AOIS XPDR 10/3
• 00643169100633: KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
• 00643169100626: CEMENTSYS KPT1005-CDS FF XPDR 10/3 1 STP
• 00643169100619: KIT KPT1501 KYPHOPAK TRAY 15/3 FF W/ITK
• 00643169100602: CEMENTSYS KPT1502-CDS OIS XPDR 15/3
• 00643169100596: CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
• 00643169100589: CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
• 00643169100572: KIT KPT2001 KYPHOPAK TRAY 20/3 FF W/ITK
• 00643169100565: CEMENTSYS KPT2002-CDS OIS XPDR 20/3
• 00643169100558: CEMENTSYS KPT2003-CDS AOIS XPDR 20/3
• 00643169100541: CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP
• 00643169096578: BONE TAMP KIT KPX103AB FF X2 10/3 AOIS
• 00643169096554: BONE TAMP KIT KPX103PB FF X2 10/3 1 STP
• 00643169096547: BONE TAMP KIT KPX103RB FF X2 10/3 OIS
• 00643169096530: BONE TAMP KIT KPX153AB FF X2 15/3 AOIS
• 00643169096516: BONE TAMP KIT KPX153PB FF X2 15/3 1 STP
• 00643169096509: BONE TAMP KIT KPX153RB FF X2 15/3 OIS
• 00643169096493: BONE TAMP KIT KPX203AB FF X2 20/3 AOIS
• 00643169096479: BONE TAMP KIT KPX203PB FF X2 20/3 1 STP
• 00643169096462: BONE TAMP KIT KPX203RB FF X2 20/3 OIS
• 00613994962362: BONE TAMP KIT KPX203PB FF X2 20/3 1 STP
• 00613994962348: BONE TAMP KIT KPX153PB FF X2 15/3 1 STP
• 00643169456105: CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP
• 00643169456099: CEMENTSYS KPT2003-CDS AOIS XPDR 20/3
• 00643169456082: CEMENTSYS KPT2002-CDS OIS XPDR 20/3
• 00643169456075: CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
• 00643169456068: CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
• 00643169456051: CEMENTSYS KPT1502-CDS OIS XPDR 15/3