GUDIDData
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gudid Primary ID: PACE 101H

PACE 101H (UDI PACE 101H)

Manufactured by Oscor Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for PACE 101H - Primary ID PACE 101H

Device Regulatory Overview

The PACE 101H (Model/Catalog Number: PACE 101H) is a medical device manufactured by Oscor Inc.. This product is indexed under FDA Product Code / Category Classification DTE 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-2678-2026 View Full Alert →

Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. hear...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0646-2022 View Full Alert →

Destino Twist 14F (also branded as Guidestar 14F)...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-2679-2026 View Full Alert →

Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and...

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

Technical Specifications

Model Number
PACE 101H
Product Code / EMDN
DTE
Device Name
Single Chamber External Pacemaker
Database Sync Date
2026-08-09 09:33:17

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 PACE 101H?

The registered manufacturer of record for PACE 101H is Oscor Inc..

What is the Primary UDI-DI identifier for PACE 101H?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is PACE 101H.

What classification code is assigned to this device?

This device is registered under product classification code DTE.

Similar Classification Devices (DTE)

Other Devices by Oscor Inc.

Programmatic Export

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

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