Balloon Kyphoplasty Essentials Kit

GUDID 00643169703544

KIT NH152PB 15/2 SPINE ESSEN FF

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit

• Primary Device ID: 00643169703544
• NIH Device Record Key: 0249a752-f69d-497b-a6ee-ea1eec9b005f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balloon Kyphoplasty Essentials Kit
• Version Model Number: NH152PB
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Store in a Cool Dry Place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169703544 [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: 2017-05-15

On-Brand Devices [Balloon Kyphoplasty Essentials Kit]

• 00643169703599: KIT NH152PB-CDS 15/2 SPINE ESSEN FF CDS
• 00643169703582: KIT NH102PB-CDS 10/2 SPINE ESSEN FF CDS
• 00643169703575: KIT NH203PB-CDS 20/3 SPINE ESSEN FF CDS
• 00643169703568: KIT NH153PB-CDS 15/3 SPINE ESSEN FF CDS
• 00643169703551: KIT NH103PB-CDS 10/3 SPINE ESSEN FF CDS
• 00643169703544: KIT NH152PB 15/2 SPINE ESSEN FF
• 00643169703537: KIT NH102PB 10/2 SPINE ESSEN FF
• 00643169703520: KIT NH203PB 20/3 SPINE ESSEN FF
• 00643169703513: KIT NH153PB 15/3 SPINE ESSEN FF
• 00643169703506: KIT NH103PB 10/3 SPINE ESSEN FF