GUDIDData
gudid Primary ID: 038-31-501U

Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1) (UDI 038-31-501U)

Manufactured by FLEXICARE MEDICAL LIMITED

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1) - Primary ID 038-31-501U

Device Regulatory Overview

The Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1) (Model/Catalog Number: 038-31-501U) is a medical device manufactured by FLEXICARE MEDICAL LIMITED. This product is indexed under FDA Product Code / Category Classification BZE within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
038-31-501U
Product Code / EMDN
BZE
Device Name
Database Sync Date
2026-08-09 09:08:18

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 Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1)?

The registered manufacturer of record for Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1) is FLEXICARE MEDICAL LIMITED.

What is the Primary UDI-DI identifier for Adult Shielded Single Limb H/W B/ Kit 1.6M (63") (Kit 1)?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 038-31-501U.

What classification code is assigned to this device?

This device is registered under product classification code BZE.

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