Silicone Block

GUDID 00684995200135

Soft, 0.5'' x 1'' x 1''

BENTEC MEDICAL OPCO, LLC

Silicone-block tissue reconstructive material

• Primary Device ID: 00684995200135
• NIH Device Record Key: 17bd460d-1612-45f4-acc2-8cec85b3a1f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Block
• Version Model Number: PR88032-221
• Company DUNS: 080524654
• Company Name: BENTEC MEDICAL OPCO, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00684995200135 [Primary]

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [Silicone Block]

• 00684995200159: X-Firm, 0.5'' x 1'' x 1''
• 00684995200142: Firm, 0.5'' x 1'' x 1''
• 00684995200135: Soft, 0.5'' x 1'' x 1''