Cement Mixing and Delivery System 00-4501-090-00

GUDID 25060238201777

Cement Mixing and Delivery System

SUMMIT MEDICAL LIMITED

Orthopaedic cement preparation/delivery kit

• Primary Device ID: 25060238201777
• NIH Device Record Key: 0fc0f48e-0ceb-4a07-b894-551e0843e339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cement Mixing and Delivery System
• Version Model Number: 00-4501-090-00
• Catalog Number: 00-4501-090-00
• Company DUNS: 221751311
• Company Name: SUMMIT MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15060238201770 [Primary]
GS1	25060238201777 [Package]; Contains: 15060238201770; Package: Carton [1 Units]; In Commercial Distribution
GS1	35060238201774 [Package]; Package: Carton [8 Units]; In Commercial Distribution

FDA Product Code

• KIH: Dispenser, Cement

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-10

On-Brand Devices [Cement Mixing and Delivery System]

• 25060238201029: Cement Mixing and Delivery System
• 25060238201777: Cement Mixing and Delivery System