Vantas

GUDID 00367979005000

ENDO PHARMACEUTICALS INC.

Subcutaneous implantation kit, medicated

• Primary Device ID: 00367979005000
• NIH Device Record Key: c6e7c4e5-a7f9-4a31-a2a1-d1e1748bdf9d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vantas
• Version Model Number: Model 001
• Company DUNS: 178074951
• Company Name: ENDO PHARMACEUTICALS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00367979005000 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-12
• Device Publish Date: 2018-06-05

Devices Manufactured by ENDO PHARMACEUTICALS INC.

• 00367979855001 - N/A: 2021-03-04
• 00367979002009 - Supprelin LA: 2019-07-12 Supprelin Kit
• 00367979005000 - Vantas: 2019-07-12
• 00367979005000 - Vantas: 2019-07-12
• 00814723020036 - MiniArc: 2019-04-23 MiniArc
• 00814723020104 - MiniArc: 2019-04-23 MiniArc Precise
• 00814723020296 - SPARC: 2019-04-23 SPARC
• 00814723020319 - Monarc: 2019-04-23 Monarc
• 00814723020340 - Monarc: 2019-04-23 Monarc +