GUDIDData
eudamed_udi Primary ID: 04049852178976

BET lateralized (128°) Stem w. TPS+HA coating (UDI 04049852178976)

Manufactured by Biotech GmbH

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BET lateralized (128°) Stem w. TPS+HA coating - Primary ID 04049852178976

Device Regulatory Overview

The BET lateralized (128°) Stem w. TPS+HA coating (Model/Catalog Number: 012-1311-0008) is a medical device manufactured by Biotech GmbH. This product is indexed under FDA Product Code / Category Classification P090804010201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
012-1311-0008
Product Code / EMDN
P090804010201
Device Name
BET Hip Stem System
Database Sync Date
2026-08-09 16:28:56

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 BET lateralized (128°) Stem w. TPS+HA coating?

The registered manufacturer of record for BET lateralized (128°) Stem w. TPS+HA coating is Biotech GmbH.

What is the Primary UDI-DI identifier for BET lateralized (128°) Stem w. TPS+HA coating?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04049852178976.

What classification code is assigned to this device?

This device is registered under product classification code P090804010201.

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