KyphPak® First Fracture Tray

GUDID 00643169671669

KIT KEX202EB-CDS- 20/2 FF WITH CDS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00643169671669
• NIH Device Record Key: 524e2e30-e7ca-4173-89e4-dbc49e7c47d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KyphPak® First Fracture Tray
• Version Model Number: KEX202EB-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: true
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (at max 25°C/77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place (at max 25°C/77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169671669 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-03

On-Brand Devices [KyphPak® First Fracture Tray]

• 00643169671843: KIT KPX203PB-CDS 20/3 FF 1-STEP WITH CDS
• 00643169671829: KIT KPX203AB-CDS 20/3 FF ADV WITH CDS
• 00643169671805: KIT KPX203RB-CDS 20/3 FF OTEO WITH CDS
• 00643169671782: KIT KPX153PB-CDS 15/3 FF 1-STEP WITH CDS
• 00643169671768: KIT KPX153AB-CDS 15/3 FF ADV WITH CDS
• 00643169671744: KIT KPX153RB-CDS 15/3 FF OSTEO WITH CDS
• 00643169671720: KIT KPX103PB-CDS 10/3 FF 1-STEP WITH CDS
• 00643169671706: KIT KPX103AB-CDS 10/3 FF ADV WITH CDS
• 00643169671683: KIT KPX103RB-CDS 10/3 FF OSTEO WITH CDS
• 00643169671669: KIT KEX202EB-CDS- 20/2 FF WITH CDS
• 00643169671645: KIT KEX152EB-CDS- 15/2 FF WITH CDS
• 00643169671621: KIT KEX102EB-CDS- 10/2 FF WITH CDS