GUDIDData
gudid Primary ID: 83-7121H

CULLUM OSTEOTOME KIT (UDI 83-7121H)

Manufactured by W.H. Holden, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for CULLUM OSTEOTOME KIT - Primary ID 83-7121H

Device Regulatory Overview

The CULLUM OSTEOTOME KIT (Model/Catalog Number: 83-7121H) is a medical device manufactured by W.H. Holden, Inc.. This product is indexed under FDA Product Code / Category Classification GFI within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
83-7121H
Product Code / EMDN
GFI
Device Name
Database Sync Date
2026-08-09 09:01:13

Full Regulatory Attributes

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

Unlock Compliance Data & Serialization Specs

Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.

Get API Token Access ($49/mo)

Frequently Asked Questions

Who is the primary manufacturer of CULLUM OSTEOTOME KIT?

The registered manufacturer of record for CULLUM OSTEOTOME KIT is W.H. Holden, Inc..

What is the Primary UDI-DI identifier for CULLUM OSTEOTOME KIT?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 83-7121H.

What classification code is assigned to this device?

This device is registered under product classification code GFI.

Programmatic Export

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

JSON API Endpoint