HYDROSET (UDI 79-43905)
Manufactured by Stryker Leibinger GmbH & Co. KG
Device Regulatory Overview
The HYDROSET (Model/Catalog Number: 79-43905) is a medical device manufactured by Stryker Leibinger GmbH & Co. KG. This product is indexed under FDA Product Code / Category Classification GXP within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 79-43905
- Product Code / EMDN
- GXP
- Device Name
- 5CC HYDROSET INJECTABLE CEMENT
- Database Sync Date
- 2026-08-09 09:45:32
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of HYDROSET?
The registered manufacturer of record for HYDROSET is Stryker Leibinger GmbH & Co. KG.
What is the Primary UDI-DI identifier for HYDROSET?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 79-43905.
What classification code is assigned to this device?
This device is registered under product classification code GXP.
Similar Classification Devices (GXP)
Other Devices by Stryker Leibinger GmbH & Co. KG
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