GENESIS SCREW-IN SUTURE ANCHOR 10B55003

GUDID 00850005827221

5.5MM SCREW-IN SUTURE ANCHOR

Genesis Biologics, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00850005827221
• NIH Device Record Key: da07f5e5-e86e-46c3-a18a-11c1257c0e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENESIS SCREW-IN SUTURE ANCHOR
• Version Model Number: 10B55003
• Catalog Number: 10B55003
• Company DUNS: 016463487
• Company Name: Genesis Biologics, 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: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM
• Phone: (657) 888-6243
• Email: ORDERS@GENESISBIOLOGICS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005827221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192484

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2023-03-24
• Device Publish Date: 2023-03-16

On-Brand Devices [GENESIS SCREW-IN SUTURE ANCHOR]

• 00850005827238: 6.5MM SCREW-IN SUTURE ANCHOR
• 00850005827221: 5.5MM SCREW-IN SUTURE ANCHOR
• 00850005827214: 4.5MM SCREW-IN SUTURE ANCHOR