DynaFuse 5mm Drill

GUDID M97031000100050

Medshape, Inc.

Cannulated surgical drill bit, reusable

• Primary Device ID: M97031000100050
• NIH Device Record Key: a19adb87-33e5-460f-b928-9dfa888dca66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaFuse 5mm Drill
• Version Model Number: 3100-01-0005
• 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	M97031000100050 [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

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

Moist Heat or Steam Sterilization

[M97031000100050]

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.

• 00810028395855 - Half pin - 3 x 100mm with 30mm thread: 2024-07-17
• 00810028395862 - Half pin - 3 x 120mm with 25mm thread: 2024-07-17
• 00810028395879 - Half pin - 3 x 120mm with 30mm thread: 2024-07-17
• 00810028395893 - Half pin - 4 x 180mm with 25mm thread: 2024-07-17
• 00810028395930 - Half pin - 5 x 180mm with 25mm thread: 2024-07-17
• 00810028395978 - Half pin - 6 x 180mm with 35mm thread: 2024-07-17
• 00810028395992 - Half pin - 4 x 180mm with 45mm thread, stepped tip: 2024-07-17
• 00810028396005 - Half pin - 5 x 180mm with 50mm thread, stepped tip: 2024-07-17