GUDIDData
Bulk Audit Tool API Access
eudamed_udi Primary ID: 00196449017386

Unspecified Brand (UDI 00196449017386)

Manufactured by Tyber Medical

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Unspecified Brand - Primary ID 00196449017386

Device Regulatory Overview

The Unspecified Brand (Model/Catalog Number: 770001080A) is a medical device manufactured by Tyber Medical. This product is indexed under FDA Product Code / Category Classification L26 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 3 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1132-2026 View Full Alert →

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: ...

🔒 Compromised Lot & Serial Numbers Locked
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ID: Z-1131-2026 View Full Alert →

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: ...

🔒 Compromised Lot & Serial Numbers Locked
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Unlock Lot Data ($49)
ID: Z-1218-2025 View Full Alert →

A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 12H RT- Anatomic Lateral Fibula Plate, 12-Hole, Right. Intended for Fixation of fractures of the dista...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)

Technical Specifications

Model Number
770001080A
Product Code / EMDN
L26
Device Name
Reusable Instrumentation
Database Sync Date
2026-08-09 16:29:02

Full Regulatory Attributes

🔒 Token Gated 
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of Unspecified Brand?

The registered manufacturer of record for Unspecified Brand is Tyber Medical.

What is the Primary UDI-DI identifier for Unspecified Brand?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 00196449017386.

What classification code is assigned to this device?

This device is registered under product classification code L26.

Similar Classification Devices (L26)

Other Devices by Tyber Medical

Programmatic Export

Export this master device record as standardized JSON or CSV for compliance audits.

JSON API Endpoint