Silicone Block 2.0 NG-BL-2.0-WF44-EZ-NS

GUDID M724NGBL20WF44EZNS1

Silicone Block 2.0, White, Firm (EZ)

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724NGBL20WF44EZNS1
• NIH Device Record Key: b396c72f-df92-4240-bbec-fc46e988438e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silicone Block 2.0
• Version Model Number: Size: 14.9cm x 7.7cm x 2.0cm
• Catalog Number: NG-BL-2.0-WF44-EZ-NS
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, 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: true
• Expiration Date: false
• 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
HIBCC	M724NGBL20WF44EZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913882

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

[M724NGBL20WF44EZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-04
• Device Publish Date: 2025-08-27

On-Brand Devices [Silicone Block 2.0]

• M724NGBL20WF44EZNS1: Silicone Block 2.0, White, Firm (EZ)
• M724NGBL20RFXSNS1: Silicone Block 2.0, Red Fleshtone, Extra Soft
• M724NGBL20RFVS5NS1: Silicone Block 2.0, Red Fleshtone, Very Soft 5
• M724NGBL20RFSEZNS1: Silicone Block 2.0, Red Fleshtone, Soft (EZ)
• M724NGBL20RFS20EZNS1: Silicone Block 2.0, Red Fleshtone, Soft 20 (EZ)
• M724NGBL20RFS15EZNS1: Silicone Block 2.0, Red Fleshtone, Soft 15 (EZ)
• M724NGBL20RFM30EZNS1: Silicone Block 2.0, Red Fleshtone Medium 30 (EZ)
• M724NGBL20OVSNS1: Silicone Block 2.0, Opaque, Very Soft
• M724NGBL20FSNS1: Silicone Block 2.0, Fleshtone, Soft
• M724NGBL20FMEZNS1: Silicone Block 2.0, Fleshtone, Medium (EZ)
• M724NGBL20FFEZNS1: Silicone Block 2.0, Fleshtone, Firm (EZ)
• M724NGBL20CVFNS1: Silicone Block 2.0, Clear, Very Firm