GUDIDData
Bulk Audit Tool API Access
gudid Primary ID: 4861-00-100

NA (UDI 4861-00-100)

Manufactured by DEPUY (IRELAND)

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for NA - Primary ID 4861-00-100

Device Regulatory Overview

The NA (Model/Catalog Number: 4861-00-100) is a medical device manufactured by DEPUY (IRELAND). This product is indexed under FDA Product Code / Category Classification LYS 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-2617-2026 View Full Alert →

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Insert Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYST...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2616-2026 View Full Alert →

Depuy Synthes, ATTUNE Revision Hinge Knee Hinge Housing Components with the below product descriptions and Part Codes. 1. ATTUNE KNEE SYS...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1993-2026 View Full Alert →

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208....

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

Technical Specifications

Model Number
4861-00-100
Product Code / EMDN
LYS
Device Name
CALCAR PLANER SLEEVE
Database Sync Date
2026-08-09 09:31:03

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 NA?

The registered manufacturer of record for NA is DEPUY (IRELAND).

What is the Primary UDI-DI identifier for NA?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4861-00-100.

What classification code is assigned to this device?

This device is registered under product classification code LYS.

Similar Classification Devices (LYS)

Other Devices by DEPUY (IRELAND)

Programmatic Export

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

JSON API Endpoint