Removal Driver, DynaFuse

GUDID M97031000000200

Medshape, Inc.

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• Primary Device ID: M97031000000200
• NIH Device Record Key: 7c2daba0-4a15-4712-93e8-77033c892197
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Removal Driver, DynaFuse
• Version Model Number: 3100-00-0020
• 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	M97031000000200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203595

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

Moist Heat or Steam Sterilization

[M97031000000200]

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
• 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