GUDIDData
gudid Primary ID: 0997-00-0986-07

ASSY CRM ITALIAN (UDI 0997-00-0986-07)

Manufactured by Datascope Corp.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ASSY CRM ITALIAN - Primary ID 0997-00-0986-07

Device Regulatory Overview

The ASSY CRM ITALIAN (Model/Catalog Number: 0997-00-0986-07) is a medical device manufactured by Datascope Corp.. This product is indexed under FDA Product Code / Category Classification DSP 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-1486-2026 View Full Alert →

CS100 IABP. Software Version CS100 IABP Q.01....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
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ID: Z-1487-2026 View Full Alert →

CS300 IABP. Software Version CS300 IABP C.01....

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0931-2026 View Full Alert →

Cardiosave Hybrid...

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

Technical Specifications

Model Number
0997-00-0986-07
Product Code / EMDN
DSP
Device Name
ASSY CRM ITALIAN
Database Sync Date
2026-08-09 09:31:01

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 ASSY CRM ITALIAN?

The registered manufacturer of record for ASSY CRM ITALIAN is Datascope Corp..

What is the Primary UDI-DI identifier for ASSY CRM ITALIAN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 0997-00-0986-07.

What classification code is assigned to this device?

This device is registered under product classification code DSP.

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