Silicone Block

GUDID B097IMD001XXL1

INTERNATIONAL MEDICAL DEVICES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: B097IMD001XXL1
• NIH Device Record Key: 4729156f-9c1e-4c3b-9501-d3a3c658902c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Block
• Version Model Number: Extra Extra Large - Extra Soft
• Company DUNS: 080156251
• Company Name: INTERNATIONAL MEDICAL DEVICES, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com
• Phone: 310-652-2600
• Email: info@intlmeddevices.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B097IMD001XXL1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042380

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

[B097IMD001XXL1]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Silicone Block]

• B097IMD006XXL1: Extra Extra Large - Soft
• B097IMD006XLO1: Extra Large - Extra Long - Soft
• B097IMD006XL1: Extra Large - Soft
• B097IMD006LLO1: Large - Extra Long - Soft
• B097IMD006L1: Large - Soft
• B097IMD001XXL1: Extra Extra Large - Extra Soft
• B097IMD001XL1: Extra Large - Extra Soft
• B097IMD001L1: Large - Extra Soft