35mm Block / Spacer

GUDID 00810028396289

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810028396289
• NIH Device Record Key: 07ca37dd-e30a-41b5-8da7-8ac4cd05805e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 35mm Block / Spacer
• Version Model Number: DNE-6000-350
• 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	00810028396289 [Primary]

FDA Product Code

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

Sterilization

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

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

[00810028396289]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-07-08
• Device Publish Date: 2024-05-31

On-Brand Devices [35mm Block / Spacer]

• 00810028397170: DNE-6000-350
• 00810028396289: DNE-6000-350