OBALON® Accessory Kit

GUDID 00859810006043

OBALON® Accessory Kit - component for use with the OBALON® Balloon System

OBALON THERAPEUTICS, INC.

Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon Appetite-suppression gastric balloon

• Primary Device ID: 00859810006043
• NIH Device Record Key: 16a55377-52bb-4ea1-8ce0-55995d762309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OBALON® Accessory Kit
• Version Model Number: 6000-0004
• Company DUNS: 022894714
• Company Name: OBALON THERAPEUTICS, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com
• Phone: 1-844-362-2566
• Email: customerservice@obalon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859810006043 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160001

FDA Product Code

• LTI: Implant, Intragastric For Morbid Obesity

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-26

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