3mm Hex Driver, T-Handle, DynaNail

GUDID M97022001300300

Medshape, Inc.

Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver Orthopaedic implant driver

• Primary Device ID: M97022001300300
• NIH Device Record Key: 7be74897-27fa-48af-aa85-4bc86521ee75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3mm Hex Driver, T-Handle, DynaNail
• Version Model Number: 2200-13-0030
• Company DUNS: 601306413
• Company Name: Medshape, 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: 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
HIBCC	M97022001300300 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

[M97022001300300]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15

Devices Manufactured by Medshape, Inc.

• M97031000000200 - Removal Driver, DynaFuse: 2024-04-09
• M97031000100050 - DynaFuse 5mm Drill: 2024-04-09
• M97031000400010 - Trajectory Wire, DynaFuse: 2024-04-09
• M97031000700010 - Parallel Pin Guide, DynaFuse: 2024-04-09
• M97031000900010 - Tissue Protector, DynaFuse: 2024-04-09
• M97031001200010 - Tube Caddy, DynaFuse: 2024-04-09
• M9703000050080 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 8mm: 2023-11-14
• M9703000050100 - Reusable Drill Guide Assembly, T-Shape, DynaClip, 10mm: 2023-11-14