KYPHON® Inflation Syringe

GUDID 00643169097155

SYRINGE A08E KIS INFLATION HP

MEDTRONIC SOFAMOR DANEK, INC.

Catheter/overtube balloon inflator, single-use Catheter/overtube balloon inflator, single-use

• Primary Device ID: 00643169097155
• NIH Device Record Key: 025d8bae-5bbd-40c0-bb0e-84dee7786df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KYPHON® Inflation Syringe
• Version Model Number: A08E
• 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	00643169097155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103231

FDA Product Code

• HXG: TAMP

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-04-02

On-Brand Devices [KYPHON® Inflation Syringe]

• 00613994686374: SYRINGE A08A KYPHX XPANDER INFLATION
• 00643169097162: SYRINGE A08A KYPHX XPANDER INFLATION
• 00643169097155: SYRINGE A08E KIS INFLATION HP
• 00858196001079: SYRINGE A08A KYPHX XPANDER INFLATION