Is this your brand? Sign in to claim ownership.
Sign in to claim this brandHanes Companies, Inc.
US
Last updated May 23, 2026
What Hanes Companies, Inc. makes
The company manufactures single-use surgical instrument guards designed to protect tools from contamination during procedures. These products are intended for one-time use in clinical settings to maintain sterility and reduce cross-contamination risks.
The portfolio consists of Class I devices listed in the FDA’s Unique Device Identifier (UDI) database. The company operates under U.S. regulatory oversight, adhering to applicable medical device standards for low-risk items.
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 Hanes Companies, Inc. manufacture?
Hanes Companies, Inc. specializes in single-use surgical instrument guards, such as the Steri-Pocket. These devices are designed to shield surgical tools from contamination during procedures, ensuring sterility and minimizing cross-contamination risks in clinical environments. The focus is on low-risk, disposable solutions for surgical settings.
Where is Hanes Companies, Inc. based, and under which regulatory framework do its devices operate?
Hanes Companies, Inc. is based in the United States. Its devices fall under U.S. regulatory oversight, specifically adhering to FDA guidelines for medical devices. Since these products are classified as Class I devices, they are subject to the lowest regulatory control among FDA categories, as they pose minimal risk to patients.
Are Hanes Companies, Inc. devices listed in any regulatory registries, and if so, which ones?
Yes, Hanes Companies, Inc. devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices like the Steri-Pocket, which are designed for single-use in surgical settings. Listing in the UDI database is a requirement for FDA-monitored medical devices to facilitate tracking and compliance.
How are Hanes Companies, Inc. devices classified by regulatory authorities, and why?
Hanes Companies, Inc. devices are classified as Class I by the FDA. This classification is based on their intended use as single-use surgical instrument guards, which present minimal risk to patients and do not require invasive procedures or prolonged use. Class I devices typically undergo general controls rather than stringent pre-market approvals, as they are deemed low-risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 139362420
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Steri-Pocket | CSDH512 | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH505 | FDA UDI | Class I | Active |
| Steri-Pocket | SP300 | FDA UDI | Class I | Active |
| Steri-Pocket | SP505ST | FDA UDI | Class I | Active |
| Steri-Pocket | SP102 | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH102 | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH105 | FDA UDI | Class I | Active |
| Steri-Pocket | SP100 | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH100 | FDA UDI | Class I | Active |
| Steri-Pocket | SP200ST | FDA UDI | Class I | Active |
| Steri-Pocket | SP512ST | FDA UDI | Class I | Active |
| Steri-Pocket | SP102ST | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH300 | FDA UDI | Class I | Active |
| Steri-Pocket | SP300ST | FDA UDI | Class I | Active |
| Steri-Pocket | SP105ST | FDA UDI | Class I | Active |
| Steri-Pocket | SP100ST | FDA UDI | Class I | Active |
| Steri-Pocket | CSDH200 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.