EASYMIX cement injector 02-0504-04

GUDID 04260056881251

The cement injector is used to apply bone cements. It is operated manually and provides a secure environment for the cartridge and a constant discharge of bone cement during application. It is made of high-grade stainless steel and designed for reuse and resterilisation. The EASYMIX® cement injector is intended to be used with the EASYMIX® mixing system to apply PMMA bone cements.

OSARTIS GmbH

Orthopaedic cement/bone filler dispensing gun

• Primary Device ID: 04260056881251
• NIH Device Record Key: 586aab3f-24f2-45e7-b58f-e7d47653556c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EASYMIX cement injector
• Version Model Number: 02-0504-04
• Catalog Number: 02-0504-04
• Company DUNS: 344261631
• Company Name: OSARTIS GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	04260056881251 [Primary]

FDA Product Code

• KIH: Dispenser, Cement

Sterilization

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

[04260056881251]

Moist Heat or Steam Sterilization

[04260056881251]

Moist Heat or Steam Sterilization

[04260056881251]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-06
• Device Publish Date: 2022-11-28

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