Silicone Sheeting Non-Reinforced

GUDID 10684995300061

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile

• Primary Device ID: 10684995300061
• NIH Device Record Key: 4c5b8c95-ccd1-453e-82e0-1cf342f9fc40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sheeting Non-Reinforced
• Version Model Number: PR72034-54N
• Company DUNS: 080524654
• Company Name: BENTEC MEDICAL OPCO, LLC
• Device Count: 2
• 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	00684995300064 [Unit of Use]
GS1	10684995300061 [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 Non-Reinforced]

• 00684995300309: PR72034-10SPN
• 00684995300293: PR72034-015SPN
• 00684995300286: PR72034-03SPN
• 00684995300279: PR72034-02SPN
• 00684995300262: PR72034-01SPN
• 00684995300255: PR72034-04SPN
• 00684995300248: PR72034-12N
• 00684995300231: PR72034-11N
• 00684995300224: PR72034-10N
• 00684995300217: PR72034-09N
• 00684995300200: PR72034-08N
• 00684995300194: PR72034-07N
• 00684995300187: PR72034-06N
• 00684995300170: PR72034-05N
• 00684995300163: PR72034-04N
• 00684995300156: PR72034-03N
• 00684995300149: PR72034-02N
• 00684995300132: PR72034-01N
• 00684995300125: PR72034-00N
• 10684995300115: PR72034-24N
• 10684995300108: PR72034-23N
• 10684995300092: PR72034-22N
• 10684995300085: PR72034-21N
• 10684995300078: PR72034-20N
• 10684995300061: PR72034-54N
• 10684995300054: PR72034-53N
• 10684995300047: PR72034-52N
• 10684995300030: PR72034-51N
• 10684995300023: PR72034-64N
• 10684995300016: PR72034-62N
• 10684995300009: PR72034-66N