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Sign in to claim this brandSurgimac LLC
US
Last updated May 23, 2026
What Surgimac LLC makes
Surgimac LLC manufactures nitrile and natural rubber examination gloves, both non-powdered and non-antimicrobial, for medical and dental use. Their portfolio also includes dental-specific products such as silicone impression materials, articulation pastes, tooth-desensitizing coatings, and reusable dental instruments like surgical probes, dressing forceps, and elevators.
The company’s devices are regulated under FDA’s Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. Surgimac LLC 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 Surgimac LLC manufacture?
Surgimac LLC specializes in gloves and dental-specific products. Their portfolio includes nitrile and natural rubber (hevea-latex) examination gloves, both non-powdered and non-antimicrobial, designed for medical and dental use. Additionally, they produce dental products like silicone impression materials, articulation pastes, tooth-desensitizing coatings, and reusable dental instruments such as surgical probes, dressing forceps, and elevators. These devices cater to both general medical and dental professional needs.
Where is Surgimac LLC based?
Surgimac LLC is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to U.S. medical device regulations, including those administered by the FDA.
Which regulatory registries or databases list Surgimac LLC’s devices?
Surgimac LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.
How are Surgimac LLC’s devices classified under FDA regulations?
Surgimac LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices are generally considered low-risk and typically require general controls, while Class II devices involve moderate risk and may 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.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- 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
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- DUNS Number
- 060635048
Catalogue (325)
Page 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MacFit | 2115-XS-CS | FDA UDI | Class I | Active |
| SurgiMac | 6116-M-Case | FDA UDI | Class I | Active |
| MacFit | 2217-M-CS | FDA UDI | Class I | Active |
| SurgiMac | 6116-XS | FDA UDI | Class I | Active |
| SurgiMac | T2218-L | FDA UDI | Class I | Active |
| SurgiMac | T5116-XS | FDA UDI | Class I | Active |
| SurgiMac | T6116-XS | FDA UDI | Class I | Active |
| SurgiMac | 16-2603 | FDA UDI | Class I | Active |
| SurgiMac | 4116S | FDA UDI | Class I | Active |
| SurgiMac | T2115XS | FDA UDI | Class I | Active |
| SurgiMac | 2217M | FDA UDI | Class I | Active |
| SurgiMac | T6116-XL | FDA UDI | Class I | Active |
| MacBite | 12178-1 | FDA UDI | Class II | Active |
| SurgiMac | 10-371-S | FDA UDI | Class I | Active |
| MacBite | BR-9005-MB | FDA UDI | Class II | Active |
| SurgiMac | T2315-XS | FDA UDI | Class I | Active |
| SurgiMac | T2319-XL | FDA UDI | Class I | Active |
| MacSoft | 9119-L | FDA UDI | Class I | Active |
| MacBite | 12178-4 | FDA UDI | Class II | Active |
| MacFit | 2115-XS | FDA UDI | Class I | Active |
| SurgiMac | 2319XL | FDA UDI | Class I | Active |
| SurgiMac | 13-1178 | FDA UDI | Class I | Active |
| MacSoft | 8116-S-CS | FDA UDI | Class I | Active |
| SurgiMac | 2318L-Case | FDA UDI | Class I | Active |
| MacSoft | 6116-M-CS | FDA UDI | Class I | Active |
| MacBite | BR-9005-MB-1 | FDA UDI | Class II | Active |
| SurgiMac | T2217-M | FDA UDI | Class I | Active |
| SurgiMac | 2316S | FDA UDI | Class I | Active |
| SurgiMac | T4116-XL | FDA UDI | Class I | Active |
| SurgiMac | 2317M | FDA UDI | Class I | Active |
| SurgiMac | 2218L-Case | FDA UDI | Class I | Active |
| MacTouch | 7116-S | FDA UDI | Class I | Active |
| MacSoft | 9119-XS-CS | FDA UDI | Class I | Active |
| SurgiMac | 2115-20-XS-Case | FDA UDI | Class I | Active |
| SurgiMac | 4116L | FDA UDI | Class I | Active |
| SurgiMac | 6116SMCASE | FDA UDI | Class I | Active |
| AlgiMac | MI-9012 | FDA UDI | Class II | Active |
| MacBite | BR-9004-MB | FDA UDI | Class II | Active |
| SurgiMac | T2119XL-Case | FDA UDI | Class I | Active |
| MacFit | 2218-L | FDA UDI | Class I | Active |
| SurgiMac | 9119-M-CS | FDA UDI | Class I | Active |
| SurgiMac | 5116LCASE | FDA UDI | Class I | Active |
| SurgiMac | T2316-S | FDA UDI | Class I | Active |
| SurgiMac | 2216S-Case | FDA UDI | Class I | Active |
| MacSoft | 6116-S-CS | FDA UDI | Class I | Active |
| SurgiMac | 90004 | FDA UDI | Class II | Active |
| SurgiMac | T2317-M | FDA UDI | Class I | Active |
| SurgiMac | 2116S | FDA UDI | Class I | Active |
| SurgiMac | 2115-20-M-Case | FDA UDI | Class I | Active |
| MacFit | 2116-S-CS | FDA UDI | Class I | Active |
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