GUDIDData
eudamed_udi Primary ID: 16972857292710

Safety Pen Needles (UDI 16972857292710)

Manufactured by Sandstone Medical(Suzhou) Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Safety Pen Needles - Primary ID 16972857292710

Device Regulatory Overview

The Safety Pen Needles (Model/Catalog Number: SPN3108D) is a medical device manufactured by Sandstone Medical(Suzhou) Inc.. This product is indexed under FDA Product Code / Category Classification A0101010201 within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
SPN3108D
Product Code / EMDN
A0101010201
Device Name
Safety Pen Needles
Database Sync Date
2026-08-09 16:29:51

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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Frequently Asked Questions

Who is the primary manufacturer of Safety Pen Needles?

The registered manufacturer of record for Safety Pen Needles is Sandstone Medical(Suzhou) Inc..

What is the Primary UDI-DI identifier for Safety Pen Needles?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 16972857292710.

What classification code is assigned to this device?

This device is registered under product classification code A0101010201.

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