GUDIDData
gudid Primary ID: LS17B20

Ligature Sleeve (UDI LS17B20)

Manufactured by Oscor Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Ligature Sleeve - Primary ID LS17B20

Device Regulatory Overview

The Ligature Sleeve (Model/Catalog Number: LS17B20) is a medical device manufactured by Oscor Inc.. This product is indexed under FDA Product Code / Category Classification DTB 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.
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ID: Z-0646-2022 View Full Alert →

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

🔒 Compromised Lot & Serial Numbers Locked
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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
LS17B20
Product Code / EMDN
DTB
Device Name
Database Sync Date
2026-08-09 09:16:46

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 Ligature Sleeve?

The registered manufacturer of record for Ligature Sleeve is Oscor Inc..

What is the Primary UDI-DI identifier for Ligature Sleeve?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is LS17B20.

What classification code is assigned to this device?

This device is registered under product classification code DTB.

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