Half pin - 3 x 100mm with 30mm thread

GUDID 00810028395855

Medshape, Inc.

Orthopaedic bone pin, non-bioabsorbable

• Primary Device ID: 00810028395855
• NIH Device Record Key: 1324beec-24c2-4917-9f4c-12e6bc6e76c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Half pin - 3 x 100mm with 30mm thread
• Version Model Number: DNE-310030
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
GS1	00810028395855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113106

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

[00810028395855]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-17
• Device Publish Date: 2024-07-09

Devices Manufactured by Medshape, Inc.

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• 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