Threaded Rod

GUDID 00810028397088

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810028397088
• NIH Device Record Key: 522b142d-eba3-494d-b198-8ecd8102e6fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Threaded Rod
• Version Model Number: DNE-27-TR
• 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	00810028397088 [Primary]

FDA Product Code

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

Sterilization

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

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

[00810028397088]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

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