AWL 5.5MM 50AWL055

GUDID 00850005827436

AWL 5.5MM

Genesis Biologics, Inc.

Bone awl, reusable

• Primary Device ID: 00850005827436
• NIH Device Record Key: 9f28cf6a-93b8-4e99-905f-2f3dd65adf69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AWL 5.5MM
• Version Model Number: 50AWL055
• Catalog Number: 50AWL055
• Company DUNS: 016463487
• Company Name: Genesis Biologics, Inc.
• 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: false
• 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

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

Device Dimensions

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005827436 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

[00850005827436]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-16
• Device Publish Date: 2024-10-08

Devices Manufactured by Genesis Biologics, Inc.

• 00850005827368 - AlternatiV+ Screw-In Anchor: 2024-10-16 4.75MM SCREW-IN SUTURE ANCHOR
• 00850005827375 - AlternatiV+ Screw-In Anchor: 2024-10-16 5.5MM SCREW-IN SUTURE ANCHOR
• 00850005827382 - AlternatiV+ Max Knotless Anchor: 2024-10-16 4.75MM MAX KNOTLESS ANCHOR
• 00850005827399 - DUAL PITCH AWL/TAPPER 4.75MM: 2024-10-16 DUAL PITCH AWL/TAPPER 4.75MM
• 00850005827405 - DUAL PITCH AWL/TAPPER 5.5MM: 2024-10-16 DUAL PITCH AWL/TAPPER 5.5MM
• 00850005827412 - AWL/TAPPER 4.5MM: 2024-10-16 AWL/TAPPER 4.5MM
• 00850005827429 - AWL 4.5MM: 2024-10-16 AWL 4.5MM
• 00850005827436 - AWL 5.5MM: 2024-10-16AWL 5.5MM
• 00850005827436 - AWL 5.5MM: 2024-10-16 AWL 5.5MM