Silicone Sheeting Non-Reinforced

GUDID 00684995300132

BENTEC MEDICAL OPCO, LLC

Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint Intestinal splint

• Primary Device ID: 00684995300132
• NIH Device Record Key: aa99ab93-23e4-4179-8f9e-3051c7c46b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Sheeting Non-Reinforced
• Version Model Number: PR72034-01N
• 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	00684995300132 [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