Silicone Blocks

GUDID 00684995200111

BENTEC MEDICAL OPCO, LLC

Silicone-block tissue reconstructive material

• Primary Device ID: 00684995200111
• NIH Device Record Key: a70b6742-c95d-415e-b37f-5063ce8f2e80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Blocks
• Version Model Number: PR88032-03
• 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	00684995200111 [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: 2017-01-11

On-Brand Devices [Silicone Blocks]

• 00684995200128: PR88032-04
• 00684995200111: PR88032-03
• 00684995200104: PR88032-02
• 00684995200098: PR88032-01
• 00684995200081: PR88032-24
• 00684995200074: PR88032-23
• 00684995200067: PR88032-22
• 00684995200050: PR88032-21
• 00684995200043: PR88032-34
• 00684995200036: PR88032-33
• 00684995200029: PR88032-32
• 00684995200012: PR88032-31
• 00684995200005: PR88032-222