Silicone Sheeting Open Border

GUDID 00684995320000

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile

• Primary Device ID: 00684995320000
• NIH Device Record Key: 8c499d97-507a-4957-82ba-2e7a07bef417
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sheeting Open Border
• Version Model Number: PR72034-01
• 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	00684995320000 [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 Sheeting Open Border]

• 00684995320079: PR72034-007
• 00684995320062: PR72034-06
• 00684995320055: PR72034-05
• 00684995320048: PR72034-04
• 00684995320031: PR72034-03
• 00684995320024: PR72034-02
• 00684995320017: PR72034-015
• 00684995320000: PR72034-01