KYPHON® Exact™ Inflatable Bone Tamp

GUDID 00858196001222

TAMP K17B KYPHX EXACT 15/3 INFLAT BONE

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp

• Primary Device ID: 00858196001222
• NIH Device Record Key: 241fee4c-cd03-4287-8fa9-1cc55f6530c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Exact™ Inflatable Bone Tamp
• Version Model Number: K17B
• 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	00858196001222 [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® Exact™ Inflatable Bone Tamp]

• 00643169158146: TAMP K17B KYPHX EXACT 15/3 INFLAT BONE
• 00643169158139: TAMP K17A KYPHX EXACT INFLATABLE BONE T
• 00858196001222: TAMP K17B KYPHX EXACT 15/3 INFLAT BONE
• 00858196001215: TAMP K17A KYPHX EXACT INFLATABLE BONE T