Block/Spacer - 100mm

GUDID 00810028396319

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810028396319
• NIH Device Record Key: 412a296c-f391-4834-be2f-17be28b811de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Block/Spacer - 100mm
• Version Model Number: DNE-6000-001
• 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: true
• 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	00810028396319 [Primary]

FDA Product Code

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

Sterilization

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

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

[00810028396319]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-09
• Device Publish Date: 2024-05-31

Devices Manufactured by Medshape, Inc.

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• M9701000032350 - Morphix XT: 2025-07-29 MORPHIX 3.5mm x 8mm Anchor with two USP
• M9701000032450 - Morphix XT: 2025-07-29 MORPHIX 4.5mm x 9mm Anchor with two USP
• M9701000041250 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 2.5MM
• M9701000042450 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 4.5MM
• M9701000042550 - Morphix XT: 2025-07-29 MORPHIX Foot and Ankle, 5.5MM
• M97012000250200 - DynaNail: 2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 20MM
• M97012000250220 - DynaNail: 2025-07-29 HEADED SCREW, DYNANAIL, CORTICAL, 22.5MM