Tube Caddy, DynaFuse

GUDID M97031001200010

Medshape, Inc.

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: M97031001200010
• NIH Device Record Key: 25deabb5-ec08-4fcf-9c37-99edd3cc72d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tube Caddy, DynaFuse
• Version Model Number: 3100-12-0001
• 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	M97031001200010 [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

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

Moist Heat or Steam Sterilization

[M97031001200010]

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.

• M97015000009200 - Eclipse: 2025-08-19 ECLIPSE, 9MM X 20MM
• M97029002402500 - DynaNail Mini: 2025-08-14 CONNECTION SCREW, M2.5, DYNANAIL MINI
• M97015000400000 - Eclipse: 2025-08-13 Tendon Spear, ExoShape Tenodesis
• M97022001100010 - DynaNail: 2025-08-13 Inline Ratchet Driver, DynaNail
• M97022002900000 - DynaNail: 2025-08-13 FRAME ASSEMBLY, CF, DYNANAIL
• M97022010900400 - DynaNail: 2025-08-13 Drill, 4.0mm x 15cm, Dynanail
• M9702300010500 - Eclipse: 2025-08-13 Acorn Reamer, 5.00mm
• M9702300010550 - Eclipse: 2025-08-13 Acorn Reamer, 5.50mm