eudamed_udi
Primary ID: 00816085021317
PROTO-FIX® (UDI 00816085021317)
Manufactured by CalibreScientific US, Inc.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PROTO-FIX® - Primary ID 00816085021317
Device Regulatory Overview
The PROTO-FIX® (Model/Catalog Number: 0004602) is a medical device manufactured by CalibreScientific US, Inc.. This product is indexed under FDA Product Code / Category Classification W0104050199 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 0004602
- Product Code / EMDN
- W0104050199
- Device Name
- Fecal Fixatives and Transport
- Database Sync Date
- 2026-08-09 17:53:44
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 PROTO-FIX®?
The registered manufacturer of record for PROTO-FIX® is CalibreScientific US, Inc..
What is the Primary UDI-DI identifier for PROTO-FIX®?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00816085021317.
What classification code is assigned to this device?
This device is registered under product classification code W0104050199.
Similar Classification Devices (W0104050199)
Other Devices by CalibreScientific US, Inc.
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