Silicone Sheeting Reinforced

GUDID 00684995310278

BENTEC MEDICAL OPCO, LLC

Silicone-sheet tissue reconstructive material, sterile

• Primary Device ID: 00684995310278
• NIH Device Record Key: 190e4a9c-4e21-474d-bcb6-fac672dbdc55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sheeting Reinforced
• Version Model Number: PR72034-01SPR
• 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	00684995310278 [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 Reinforced]

• 00684995310322: PR72034-15SPR
• 00684995310315: PR72034-04SPR
• 00684995310308: PR72034-03SPR
• 00684995310292: PR72034-02SPR
• 00684995310285: PR72034-010SPR
• 00684995310278: PR72034-01SPR
• 00684995310254: PR72034-44R
• 00684995310247: PR72034-43R
• 00684995310230: PR72034-42R
• 00684995310223: PR72034-41R
• 00684995310216: PR72034-407R
• 00684995310209: PR72034-14R
• 00684995310155: PR72034-12R
• 00684995310148: PR72034-10R
• 00684995310131: PR72034-08R
• 00684995310124: PR72034-07R
• 00684995310117: PR72034-06R
• 00684995310100: PR72034-05R
• 00684995310094: PR72034-04R
• 00684995310087: PR72034-03R
• 00684995310070: PR72034-02R
• 00684995310063: PR72034-01R
• 00684995310056: PR72034-007R
• 10684995310268: PR72034-07SPR
• 10684995310190: PR72034-62R
• 10684995310183: PR72034-64R
• 10684995310176: PR72034-63R
• 10684995310169: PR72034-60R
• 10684995310046: PR72034-55R
• 10684995310039: PR72034-54R
• 10684995310022: PR72034-53R
• 10684995310015: PR72034-52R
• 10684995310008: PR72034-51R