ManuMix 02-0602

GUDID 04260056881572

ManuMix® is a mixing system for bone cements of low to medium viscosity and subsequent transfer in syringes for clinical application.

OSARTIS GmbH

Manual orthopaedic cement mixer, single-use

• Primary Device ID: 04260056881572
• NIH Device Record Key: dfad0214-b60b-48f6-b9d4-481fda4602bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManuMix
• Version Model Number: 02-0601
• Catalog Number: 02-0602
• Company DUNS: 344261631
• Company Name: OSARTIS GmbH
• 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: false
• Expiration Date: true
• 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	04260056881565 [Primary]
GS1	04260056881572 [Package]; Contains: 04260056881565; Package: Shipping unit [10 Units]; In Commercial Distribution

FDA Product Code

• JDZ: Mixer, Cement, For Clinical Use

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: 2021-10-20
• Device Publish Date: 2021-10-12

Devices Manufactured by OSARTIS GmbH

• 04260056882579 - BonOs HV: 2024-05-27 BonOs® HV is a fast-setting acrylic resin for use in bone surgery. Mixing the two separate sterile components produces a ductil
• 04260056882623 - BonOs HV Genta: 2024-04-11 BonOs® HV Genta is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two sep
• 14260056880619 - EASYMIX® Nozzle slim: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 14260056880916 - EASYMIX® Nozzle revision: 2022-12-09 The vacuum mixing systems EASYMIX® is a mixing systems for PMMA bone cements, which are indicated to be used with a mixing syst
• 04260056881022 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, Medap wall coupling. The compressed air hoses connect the EASYMIX® vacuum pump to the compr
• 04260056881039 - EASYMIX® compressed air hose: 2022-12-09 EASYMIX® compressed air hose, 5 m, DIN 13260-2 wall coupling. Compressed air hoses connect the EASYMIX® vacuum pump to the com
• 04260056881633 - EASYMIX® vacuum pump I: 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c
• 04260056881930 - EASYMIX® vacuum pump II: 2022-12-09 The devices are used with an EASYMIX® vacuum mixing system to reduce air entrapment in bone cement. The pump is operated with c