KYPHON® Express™ Inflatable Bone Tamp

GUDID 00858196001628

TAMP K15B IBT KYPHX EXPRESS SIZE 15/2

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00858196001628
• NIH Device Record Key: 294a9bc1-8108-4b0a-a599-2184fd6e1b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Express™ Inflatable Bone Tamp
• Version Model Number: K15B
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858196001628 [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 [KYPHON® Express™ Inflatable Bone Tamp]

• 00613994721266: TAMP K15B IBT KYPHX EXPRESS SIZE 15/2
• 00643169143791: BONE TAMP KE102 10/2 EXPRESS II IBT
• 00643169143777: BONE TAMP KE152 15/2 EXPRESS II IBT
• 00643169143753: BONE TAMP KE202 20/2 EXPRESS II IBT
• 00643169103092: TAMP K15B EXPRESS SIZE 15/2
• 00643169103085: TAMP K15A EXPRESS SIZE 10/2
• 00858196001628: TAMP K15B IBT KYPHX EXPRESS SIZE 15/2
• 00858196001185: TAMP K15A IBT KYPHX EXPRESS SIZE 10/2
• 00763000312008: TAMP K15B IBT KYPHX EXPRESS SIZE 15/2
• 00763000311995: TAMP K15A IBT KYPHX EXPRESS SIZE 10/2