Summit Strip

GUDID 00812593021986

Summit Strip 2.5cm x 10cm x 0.8cm

Biogennix, LLC

Synthetic bone graft

• Primary Device ID: 00812593021986
• NIH Device Record Key: 4eabccd9-9049-4fd8-a5e0-7683eccbe5bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summit Strip
• Version Model Number: 924310
• Company DUNS: 832270370
• Company Name: Biogennix, 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: false
• 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	00812593021986 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193487

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [Summit Strip]

• 00812593021986: Summit Strip 2.5cm x 10cm x 0.8cm
• 00812593021979: Summit Strip 2.5cm x 5xm x 0.8cm