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Surgi-Pak, Inc.

US

Last updated May 24, 2026

What Surgi-Pak, Inc. makes

Surgi-Pak, Inc. manufactures single-use surgical and medical supplies, including absorbent tip applicators, radiopaque woven sponges, non-latex pressure bandages, medical fibre padding, stockinette, gauze pads, tubular support bandages, and non-medicated surgical procedure kits.

All products fall under FDA Class I medical devices and are listed in the FDA’s Unique Device Identification (UDI) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Surgi-Pak, Inc. manufacture?

Surgi-Pak, Inc. specializes in single-use surgical and medical supplies. Their product line includes general-purpose absorbent tip applicators/swabs, radiopaque woven surgical sponges, non-latex pressure bandages, medical fibre padding, stockinette, woven gauze pads (non-antimicrobial), tubular support bandages (non-latex), and non-medicated surgical procedure kits. These devices are designed for one-time clinical use to support wound care, surgical procedures, and patient hygiene.

Where is Surgi-Pak, Inc. based, and how does that affect its regulatory standing?

Surgi-Pak, Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies all of Surgi-Pak’s products as Class I medical devices, which are generally considered to pose the lowest risk to patients. This classification means the devices are subject to general controls (e.g., manufacturing practices, labeling requirements) but typically do not require pre-market approval.

Are Surgi-Pak, Inc.’s devices listed in any regulatory registries, and why does this matter?

Yes, Surgi-Pak, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry assigns a unique identifier to each device, improving traceability, reducing medical errors, and facilitating post-market surveillance. Listing in the UDI database ensures healthcare providers and regulators can quickly verify device details, such as manufacturer information, model specifications, and batch details, which supports patient safety and compliance.

How are Surgi-Pak, Inc.’s devices classified by the FDA, and what does that mean for their use?

The FDA categorizes all of Surgi-Pak, Inc.’s devices as Class I, the lowest risk classification for medical devices. This classification means the devices are subject to basic regulatory controls, such as good manufacturing practices (GMP) and proper labeling, but they do not require pre-market approval or rigorous clinical trials. Class I devices are typically considered safe and effective through established manufacturing standards and are commonly used in routine clinical settings, such as surgical sponges, bandages, and applicators.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
LinkedIn
—
Facebook
—
Phone
6269683335
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
152736971

Catalogue (141)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
National Hospital Packaging 11-032
FDA UDI
Class IActive
National Hospital Packaging 13-008
FDA UDI
Class IActive
National Hospital Packaging 13-016
FDA UDI
Class IActive
National Hospital Packaging 25-002
FDA UDI
Class IActive
National Hospital Packaging 13-009DB
FDA UDI
Class IActive
National Hospital Packaging 16-105
FDA UDI
Class IActive
National Hospital Packaging 2127-S
FDA UDI
Class IActive
National Hospital Packaging 24-007
FDA UDI
Class IActive
National Hospital Packaging 36-024
FDA UDI
Class IActive
National Hospital Packaging 13-007WO
FDA UDI
Class IActive
National Hospital Packaging 24-082
FDA UDI
Class IActive
National Hospital Packaging 7644
FDA UDI
Class IActive
National Hospital Packaging 13-009
FDA UDI
Class IActive
National Hospital Packaging 19-001 NS1
FDA UDI
Class IActive
National Hospital Packaging 10-012
FDA UDI
Class IActive
National Hospital Packaging 11-004
FDA UDI
Class IActive
National Hospital Packaging 10-043
FDA UDI
Class IActive
National Hospital Packaging 20-002
FDA UDI
Class IActive
National Hospital Packaging 10-029S
FDA UDI
Class IActive
National Hospital Packaging 10-030
FDA UDI
Class IActive
National Hospital Packaging 10-022
FDA UDI
Class IActive
National Hospital Packaging 13-001WO
FDA UDI
Class IActive
National Hospital Packaging 10-030S
FDA UDI
Class IActive
National Hospital Packaging 13-009WO
FDA UDI
Class IActive
National Hospital Packaging 19-002
FDA UDI
Class IActive
National Hospital Packaging 16-001
FDA UDI
Class IActive
National Hospital Packaging 13-002DB
FDA UDI
Class IActive
National Hospital Packaging 17-005
FDA UDI
Class IActive
National Hospital Packaging 24-024LF
FDA UDI
Class IActive
National Hospital Packaging 25-001
FDA UDI
Class IActive
National Hospital Packaging 13-006
FDA UDI
Class IActive
National Hospital Packaging 10-006
FDA UDI
Class IActive
National Hospital Packaging 32-002
FDA UDI
Class IActive
National Hospital Packaging 18-001
FDA UDI
Class IActive
National Hospital Packaging 13-016WO
FDA UDI
Class IActive
National Hospital Packaging 24-006
FDA UDI
Class IActive
National Hospital Packaging 8172NS
FDA UDI
Class IActive
National Hospital Packaging 8264
FDA UDI
Class IActive
National Hospital Packaging 24-092
FDA UDI
Class IActive
National Hospital Packaging 26-002R
FDA UDI
Class IActive
National Hospital Packaging 12-001
FDA UDI
Class IActive
National Hospital Packaging 7785
FDA UDI
Class IActive
National Hospital Packaging 17-006
FDA UDI
Class IActive
National Hospital Packaging 7743
FDA UDI
Class IActive
National Hospital Packaging 11-013
FDA UDI
Class IActive
National Hospital Packaging 24-003
FDA UDI
Class IActive
National Hospital Packaging 28-002
FDA UDI
Class IActive
National Hospital Packaging 13-001DB
FDA UDI
Class IActive
National Hospital Packaging 24-026LF
FDA UDI
Class IActive
National Hospital Packaging 13-003WO
FDA UDI
Class IActive

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