Factor VIII Deficient Substrate Plasma (UDI 5193)
Manufactured by HELENA LABORATORIES CORPORATION
Device Regulatory Overview
The Factor VIII Deficient Substrate Plasma (Model/Catalog Number: 5193) is a medical device manufactured by HELENA LABORATORIES CORPORATION. This product is indexed under FDA Product Code / Category Classification GGP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 5193
- Product Code / EMDN
- GGP
- Device Name
- Database Sync Date
- 2026-08-09 09:36:16
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 Factor VIII Deficient Substrate Plasma?
The registered manufacturer of record for Factor VIII Deficient Substrate Plasma is HELENA LABORATORIES CORPORATION.
What is the Primary UDI-DI identifier for Factor VIII Deficient Substrate Plasma?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 5193.
What classification code is assigned to this device?
This device is registered under product classification code GGP.
Similar Classification Devices (GGP)
Other Devices by HELENA LABORATORIES CORPORATION
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