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Sign in to claim this brandLACEY MANUFACTURING COMPANY LLC
US
Last updated September 17, 2026
What LACEY MANUFACTURING COMPANY LLC makes
Lacey Manufacturing Company LLC produces single-use surgical instruments, including scalpels, bone access cannulas, and endoscopic electrosurgical handpieces with bipolar and monopolar electrodes. Their portfolio also covers specialized needles like the BE-ST PAK Access Needle and BE-ST NIM PAK Needle Bevel, as well as bipolar forceps and trocars designed for minimally invasive procedures.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Operations are based in the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
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 Lacey Manufacturing Company LLC primarily manufacture?
Lacey Manufacturing Company LLC specializes in single-use surgical instruments. Their portfolio includes scalpels, bone access cannulas, and endoscopic electrosurgical handpieces with both bipolar and monopolar electrodes. They also produce specialized devices like the BE-ST PAK Access Needle, BE-ST NIM PAK Needle Bevel, and various trocars and forceps designed for minimally invasive procedures. These devices are intended for use in surgical settings where disposability and precision are critical.
Where is Lacey Manufacturing Company LLC based, and how does this affect its regulatory compliance?
Lacey Manufacturing Company LLC is based in the United States. As a US-based manufacturer, their devices must comply with FDA regulations, including classification under FDA’s Class I or Class II categories. The company’s operations are subject to FDA oversight, and their devices are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and regulatory transparency.
Which regulatory registries or databases list devices manufactured by Lacey Manufacturing Company LLC?
Devices produced by Lacey Manufacturing Company LLC are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, monitoring, and regulatory compliance. This listing helps healthcare providers, regulators, and other stakeholders verify and access critical information about the devices.
How are devices from Lacey Manufacturing Company LLC classified under FDA regulations?
Lacey Manufacturing Company LLC’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require less regulatory scrutiny, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as determined by FDA guidelines.
Why are some of Lacey Manufacturing Company LLC’s devices listed as single-use, and what does that mean for their use?
Lacey Manufacturing Company LLC’s devices are designed as single-use to ensure sterility, safety, and consistency in surgical procedures. Single-use instruments are intended for one-time use only and are discarded after use to prevent cross-contamination and reduce the risk of infection. This design choice aligns with best practices in surgical settings, where reusing instruments could introduce microbial risks or compromise precision.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 1146 Barnum Ave, BRIDGEPORT, CT, 06610
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 1218017
- DUNS Number
- —
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Best | 1587-06 | FDA UDI | Class I | Active |
| Best | 1587-02 | FDA UDI | Class I | Active |
| Best | 1571-00 | FDA UDI | Class I | Active |
| BEST PAK Access Needle | PK1004 | FDA UDI | Class I | Active |
| BE-ST ElectroCautery Pencil | 1560-02 | FDA UDI | Class II | Active |
| BE-ST NIM PAK Needle Bevel | PK1006 | FDA UDI | Class II | Active |
| BE-ST Bipolar Forceps | 1590-00 | FDA UDI | Class II | Active |
| Best | 1600-01 | FDA UDI | Class I | Active |
| Best | 1587-07 | FDA UDI | Class I | Active |
| BE-ST NIM PAK Needle Trocar | PK1007 | FDA UDI | Class II | Active |
| BE-ST Bipolar Forceps | 1590-02 | FDA UDI | Class II | Active |
| BE-ST NIM XPAK Needle Trocar | PK1009 | FDA UDI | Class II | Active |
| Best | 1563-01 | FDA UDI | Class I | Active |
| Best | 1587-05 | FDA UDI | Class I | Active |
| Boston Endo Surgical Technologies LLC | PK1015 | FDA UDI | Class II | Active |
| Best | 1587-00 | FDA UDI | Class I | Active |
| Best | 1564-00 | FDA UDI | Class I | Active |
| BEST PAK Access Needle | PK1002 | FDA UDI | Class I | Active |
| BE-ST ElectroCautery Pencil | 1560-03 | FDA UDI | Class II | Active |
| Best | 1587-01 | FDA UDI | Class I | Active |
| Best | 1587-09 | FDA UDI | Class I | Active |
| Best | 1563-02 | FDA UDI | Class I | Active |
| BEST PAK Access Needle | PK1001 | FDA UDI | Class I | Active |
| Best | 1563-00 | FDA UDI | Class I | Active |
| Boston Endo Surgical Technologies LLC | PK1011 | FDA UDI | Class II | Active |
| Best | 1600-02 | FDA UDI | Class I | Active |
| Boston Endo Surgical Technologies LLC | 1590-11 | FDA UDI | Class II | Active |
| BEST PAK Access Needle | PK1005 | FDA UDI | Class I | Active |
| Best | 1587-08 | FDA UDI | Class I | Active |
| Best | 1587-03 | FDA UDI | Class I | Active |
| BE-ST NIM XPAK Needle Blunt | PK1010 | FDA UDI | Class II | Active |
| Boston Endo Surgical Technologies LLC | PK1013 | FDA UDI | Class II | Active |
| BE-ST Bipolar Forceps | 1590-01 | FDA UDI | Class II | Active |
| BE-ST Bipolar Forceps Straight | 1590-07 | FDA UDI | Class II | Active |
| Best | 1587-04 | FDA UDI | Class I | Active |
| Boston Endo Surgical Technologies LLC | 1590-10 | FDA UDI | Class II | Active |
| Best | 1587-11 | FDA UDI | Class I | Active |
| BE-ST Bipolar Forceps | 1590-03 | FDA UDI | Class II | Active |
| BEST PAK Access Needle | PK1003 | FDA UDI | Class I | Active |
| Boston Endo Surgical Technologies LLC | PK1014 | FDA UDI | Class II | Active |
| Boston Endo Surgical Technologies LLC | PK1012 | FDA UDI | Class II | Active |
| BE-ST NIM XPAK Needle Bevel | PK1008 | FDA UDI | Class II | Active |
| BE-ST ElectroCautery Pencil | 9569575 | FDA UDI | Class II | Active |
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