Tissue Protector, DynaFuse

GUDID M97031000900010

Medshape, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M97031000900010
• NIH Device Record Key: 29231348-f7b6-4ebf-b0bd-43ab19f904bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tissue Protector, DynaFuse
• Version Model Number: 3100-09-0001
• Company DUNS: 601306413
• Company Name: Medshape, 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: 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	M97031000900010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203595

FDA Product Code

• JEC: Component, Traction, Invasive

Sterilization

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

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

[M97031000900010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

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
• 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