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Sign in to claim this brandROBERT BUSSE & CO., INC.
US
Last updated May 24, 2026
What ROBERT BUSSE & CO., INC. makes
Robert Busse & Co., Inc. manufactures single-use and reusable medical devices for epidural anaesthesia, including non-medicated and medicated epidural anaesthesia sets and non-threaded epidural needles. The company also produces laparoscopic access cannulas, general surgical procedure kits (both medicated and non-medicated), lumbar puncture kits, and medicated wound dressing kits.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in 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 Robert Busse & Co., Inc. manufacture?
Robert Busse & Co., Inc. specializes in medical devices primarily used in anaesthesia, surgery, and wound care. Their portfolio includes epidural anaesthesia sets (both non-medicated and medicated), epidural needles (non-threaded), laparoscopic access cannulas, general surgical procedure kits (single-use, medicated or non-medicated), lumbar puncture kits, and medicated wound dressing kits. These devices are designed for single-use or reusable applications depending on the category.
Where is Robert Busse & Co., Inc. based, and what does that mean for their regulatory oversight?
Robert Busse & Co., Inc. is based in the United States, which means their devices fall under FDA jurisdiction. The FDA classifies their products as either Class I or Class II, depending on the risk level and intended use. This classification determines the regulatory pathway for authorization, such as 510(k) clearance for Class II devices or general controls for Class I devices.
Are Robert Busse & Co., Inc.’s devices listed in any regulatory registries, and why does this matter?
Yes, Robert Busse & Co., Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system ensures traceability, reduces medical errors, and improves patient safety by providing standardized identification for devices. It also helps healthcare providers and regulators track devices throughout their lifecycle, from manufacturing to post-market surveillance.
How are Robert Busse & Co., Inc.’s devices classified by the FDA, and what does that classification imply?
Robert Busse & Co., Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices are generally low-risk and typically subject to general controls like good manufacturing practices (GMP). Class II devices involve a higher risk and may require premarket notification (510(k)) to demonstrate substantial equivalence to a predicate device. The classification ensures appropriate regulatory oversight based on the device’s risk level and intended use.
What does it mean for a device to be listed in the FDA’s UDI database, and how does it benefit healthcare providers?
Listing in the FDA’s UDI database means the device has been assigned a unique identifier, combining a device identifier (like a model number) and a production identifier (like a batch/lot number). This benefits healthcare providers by enabling better inventory management, reducing counterfeit risks, and facilitating quicker recalls or safety alerts. It also supports electronic health records and improves transparency in the supply chain.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- busseinc.com
- —
- —
- [email protected]
- Phone
- 1 (631) 435-4711
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 002418234
Catalogue (931)
Page 19 of 19| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Busse Hospital Disposables | 3122 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | B1568 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 9342 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 6388 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 139 | FDA UDI | Class I | Active |
| Busse Hospital Disposables | 3304 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 6236R1 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 7369 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | B1118 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 7040 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 2907R2 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 3530 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 6796R1 | FDA UDI | Class II | Unknown |
| Busse Hospital Disposables | 3557R1 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 7358 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 671 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 2327R1 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 6447 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 1155R5 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 3897 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 9119 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 7993 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 3129 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 8217 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 746 | FDA UDI | Class I | Active |
| Busse Hospital Disposables | B9806 | FDA UDI | Class II | Unknown |
| Busse Hospital Disposables | 2385 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 6256R1 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 8234 | FDA UDI | Class II | Active |
| Busse Hospital Disposables | 1235 | FDA UDI | Class II | Active |
| Loss Of Resistance Syringe | K061737 | FDA 510(k) | Class II | Active |
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