GUDIDData
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gudid Primary ID: IN-2020-8077

INSTRUSAFE (UDI IN-2020-8077)

Manufactured by Summit Medical, Inc.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for INSTRUSAFE - Primary ID IN-2020-8077

Device Regulatory Overview

The INSTRUSAFE (Model/Catalog Number: IN-2020-8077) is a medical device manufactured by Summit Medical, Inc.. This product is indexed under FDA Product Code / Category Classification KCT 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-1319-2013 View Full Alert →

Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest Parkway, Suite 100, St. Paul, MN...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-0435-2016 View Full Alert →

AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx...

🔒 Compromised Lot & Serial Numbers Locked
Verify if facility inventory is affected by this recall.
Unlock Lot Data ($49)
ID: Z-1731-2014 View Full Alert →

Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provi...

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

Technical Specifications

Model Number
IN-2020-8077
Product Code / EMDN
KCT
Device Name
Database Sync Date
2026-08-09 10:02:39

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 INSTRUSAFE?

The registered manufacturer of record for INSTRUSAFE is Summit Medical, Inc..

What is the Primary UDI-DI identifier for INSTRUSAFE?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is IN-2020-8077.

What classification code is assigned to this device?

This device is registered under product classification code KCT.

Similar Classification Devices (KCT)

Other Devices by Summit Medical, Inc.

Programmatic Export

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

JSON API Endpoint