Ventral Wall Defect Silo Bag

GUDID 00684995400016

BENTEC MEDICAL OPCO, LLC

Gastroschisis silo bag

• Primary Device ID: 00684995400016
• NIH Device Record Key: 1dc17b5c-a3d0-4a3e-a5d4-e5d756989312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventral Wall Defect Silo Bag
• Version Model Number: GR74089-02
• Company DUNS: 080524654
• Company Name: BENTEC MEDICAL OPCO, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00684995400016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K840172

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-10
• Device Publish Date: 2017-01-03

On-Brand Devices [Ventral Wall Defect Silo Bag]

• 00684995400061: GR74089-07
• 00684995400054: GR74089-06
• 00684995400047: GR74089-05
• 00684995400030: GR74089-04
• 00684995400023: GR74089-03
• 00684995400016: GR74089-02
• 00684995400009: GR74089-01