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Sign in to claim this brandBLACK & BLACK SURGICAL, INC.
United States·US-MF-000033124
Last updated September 17, 2026
What BLACK & BLACK SURGICAL, INC. makes
The company manufactures reusable and single-use surgical instruments for plastic surgery and general surgery, including liposuction cannulas, hand-held retractors, monopolar electrosurgical electrodes, surgical scissors, forceps, fibreoptic light cables, and plastic surgery files/rasps.
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 company 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 Black & Black Surgical, Inc. manufacture?
Black & Black Surgical, Inc. specializes in reusable and single-use surgical instruments primarily used in plastic and general surgery. Their product lineup includes liposuction cannulas (both reusable and disposable), hand-held surgical retractors, monopolar electrosurgical electrodes, general-purpose surgical scissors, soft-tissue manipulation forceps, fibreoptic light cables, and plastic surgery files/rasps. These tools are designed for procedures requiring precision and sterility in operating environments.
Where is Black & Black Surgical, Inc. based, and what does that mean for its regulatory oversight?
Black & Black Surgical, Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their instruments as either Class I or Class II, depending on the risk associated with the device’s use and intended purpose. This classification determines the level of scrutiny and regulatory requirements the devices must meet.
Which regulatory registries or databases list Black & Black Surgical, Inc.’s devices?
Black & Black Surgical, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identify medical devices throughout their distribution and helps ensure traceability, transparency, and compliance with regulatory requirements. This listing is essential for tracking devices in clinical settings and maintaining regulatory records.
How are Black & Black Surgical, Inc.’s devices classified by the FDA, and why does this matter?
Black & Black Surgical, Inc.’s devices are classified under FDA’s Class I and Class II categories. Class I devices are generally considered low-risk and may require only general controls like good manufacturing practices. Class II devices pose a higher risk and require additional controls, such as special labeling or performance standards, to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device, influencing how they are reviewed, approved, and monitored.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 5175 S Royal Atlanta Drive, Tucker, United States
- Website
- blackandblacksurgical.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Cynthia Rees
- EUDAMED SRN
- US-MF-000033124
- FDA FEI Number
- 3006142527
- DUNS Number
- —
Catalogue (559)
Page 5 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Black & Black Surgical | B62187 | FDA UDI | Class I | Active |
| Black & Black Surgical | B8BX-DBAS-430 PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | 8BX-BAS-430 ANGSP PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XBECD-332L | FDA UDI | Class I | Active |
| Black & Black Surgical | B57906 | FDA UDI | Class I | Active |
| Bipolar Scissors | B68750 | FDA UDI | Class II | Active |
| Black & Black Surgical, Inc. | B8BX-LVH-320-9H ANG PWR | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B86-FIC-1410-KLL | FDA UDI | Class I | Active |
| Black & Black Surgical | B68950 | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B86-REB-325 EH | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XFIC-I-CC1620-LL | FDA UDI | Class I | Active |
| Bipolar Scissors | B68740 | FDA UDI | Class II | Active |
| Black & Black Surgical | B8BX-STE-422 90d PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XIII-CC426L-ANG | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XDSPA-318L | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B54349 | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B86-MER-325 EH | FDA UDI | Class I | Active |
| Black & Black Surgical | B89HCC | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B8XSR-222.5 | FDA UDI | Class I | Active |
| Black & Black Surgical | B62091 | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B8XMER-426L-CVD-AH | FDA UDI | Class I | Active |
| Black & Black Surgical | B91074 | FDA UDI | Class I | Active |
| Dissection Needle | B68016 | FDA UDI | Class II | Active |
| Fiberoptic Cable | B79722 | FDA UDI | Class II | Active |
| Black & Black Surgical, Inc. | B8XCC-324L-MLA | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B53150 | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B8BX-DMIII-432 PWR | FDA UDI | Class I | Active |
| Tebbetts Hand-Activated Monopolar Insulated Forcep | B65240 | FDA UDI | Class II | Active |
| Black & Black Surgical, Inc. | B3FRS-21 RM-8 | FDA UDI | Class I | Active |
| Black & Black Surgical | B64076 | FDA UDI | Class I | Active |
| Black & Black Surgical | B8BX-BAS-430-SPTPRU PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | B8BX-MER-332 PWR | FDA UDI | Class I | Active |
| Fiberoptic Cable | B79767 | FDA UDI | Class II | Active |
| Black & Black Surgical | B8BX-MIII-432 ANG PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | B67002-1X | FDA UDI | Class I | Active |
| Black & Black Surgical | B8BX-SAT40-332 PWR | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XHLX-326L | FDA UDI | Class I | Active |
| Black & Black Surgical | B8B-DMER-440 PWR | FDA UDI | Class I | Active |
| Fiberoptic Cable | B79726 | FDA UDI | Class II | Active |
| Black & Black Surgical, Inc. | B8XSAT-636L | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XSTD-II-189-LL | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B86-FIC-1020-KLL | FDA UDI | Class I | Active |
| Black & Black Surgical | B53064X | FDA UDI | Class I | Active |
| Black & Black Surgical | B60046X | FDA UDI | Class I | Active |
| Fiberoptic Cable | B79719 | FDA UDI | Class II | Active |
| Black & Black Surgical | B8XIII-326L-CC-CVD | FDA UDI | Class I | Active |
| Black & Black Surgical | B8XSPA-27L | FDA UDI | Class I | Active |
| Black & Black Surgical, Inc. | B89139 | FDA UDI | Class II | Active |
| Infiltration Tubing | B89216 | FDA UDI | Class II | Active |
| Black & Black Surgical | B8BX-STE-622 PWR | FDA UDI | Class I | Active |
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