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Sign in to claim this brandMICROSPECIALITIES, INC.
US
Last updated May 24, 2026
What MICROSPECIALITIES, INC. makes
The company manufactures single-use ophthalmic surgical instruments and accessories, including non-medicated procedure kits, knives, sponges, drapes, lacrimal punctum plugs, vented postsurgical eye shields, and skin marking guides. These products are designed for use in eye surgeries and related procedures, ensuring sterile and precise applications during medical interventions.
The portfolio includes devices classified as Class I, Class II, and unclassified (U) under regulatory frameworks, with several entries listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable domestic and international regulatory standards for medical devices.
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 Microspecialties, Inc. manufacture?
Microspecialties, Inc. specializes in single-use ophthalmic surgical devices and accessories. These include non-medicated surgical procedure kits, single-use ophthalmic knives, sponges, drapes, lacrimal punctum plugs, vented postsurgical eye shields, and skin marking guides. All products are designed for sterile use in eye surgeries and related procedures.
Where is Microspecialties, Inc. based, and what does that mean for its regulatory compliance?
Microspecialties, Inc. is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company manufactures devices classified as Class I, Class II, and unclassified (U), it must follow applicable domestic and international standards to ensure safety, performance, and compliance with regulatory frameworks.
Which regulatory registries list Microspecialties, Inc.’s devices?
Several of Microspecialties, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability in regulatory oversight.
How are Microspecialties, Inc.’s devices classified under regulatory frameworks?
Microspecialties, Inc.’s devices fall into different regulatory classes: Class I (generally low-risk), Class II (moderate-risk with special controls), and unclassified (U) devices. The classification determines the level of regulatory scrutiny and requirements, such as pre-market notifications, post-market surveillance, or labeling standards, depending on the device’s risk profile.
Why do some of Microspecialties, Inc.’s devices appear as ‘Pro-Paks’ in listings?
The repeated appearance of ‘Pro-Paks’ in listings reflects the company’s core product line, which consists of single-use ophthalmic surgical procedure kits. These kits bundle essential tools like knives, sponges, drapes, and other accessories into a sterile, ready-to-use package for surgical procedures, ensuring consistency and efficiency in ophthalmic surgeries.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- pro-paks.com
- —
- —
- [email protected]
- Phone
- 203-874-1832
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 013469890
Catalogue (164)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Pro-Paks | 21671G | FDA UDI | Class II | Active |
| Pro-Paks | MK-7022 | FDA UDI | Class I | Active |
| Pro-Paks | MK-7817 | FDA UDI | Class I | Active |
| Pro-Paks | 221127E | FDA UDI | Class II | Active |
| Pro-Paks | 21461D | FDA UDI | Class II | Active |
| Pro-Paks®️ | PD117 | FDA UDI | Class II | Active |
| Pro-Paks | 221101C | FDA UDI | Class II | Active |
| Pro-Paks | 21437N | FDA UDI | Class II | Active |
| Pro-Paks | MK-9001 | FDA UDI | Class I | Active |
| Pro-Paks | 218031B | FDA UDI | Class II | Active |
| Pro-Paks | 221099B | FDA UDI | Class II | Active |
| Pro-Paks®️ | MK-302 | FDA UDI | Class II | Active |
| Pro-Paks | 21435G | FDA UDI | Class II | Active |
| Pro-Paks | 221007A | FDA UDI | Class II | Active |
| Pro-Paks | 21673I | FDA UDI | Class II | Active |
| Pro-Paks | 218024B | FDA UDI | Class II | Active |
| Pro-Paks®️ | PD801 | FDA UDI | Class II | Active |
| Pro-Paks | 221033B | FDA UDI | Class II | Active |
| Pro-Paks | 21442E | FDA UDI | Class II | Active |
| Pro-Paks | 2002PL | FDA UDI | Class I | Active |
| Pro-Paks | MK-7127 | FDA UDI | Class I | Active |
| Pro-Paks | 218026D | FDA UDI | Class II | Active |
| Pro-Paks | MK-7814 | FDA UDI | Class I | Active |
| Pro-Paks | MK-7226 | FDA UDI | Class I | Active |
| Pro-Paks | 694C | FDA UDI | Class II | Active |
| Pro-Paks®️ | MK-109 | FDA UDI | Class II | Active |
| Pro-Paks | 21710A | FDA UDI | Class II | Active |
| Pro-Paks | 221100B | FDA UDI | Class II | Active |
| Pro-Paks®️ | PD320 | FDA UDI | Class II | Active |
| Pro-Paks | ES Basic | FDA UDI | Class I | Active |
| Comfortear™ | 32-2004 | FDA UDI | U | Active |
| Pro-Paks | MK-7304 | FDA UDI | Class I | Active |
| Pro-Paks®️ | PD360 | FDA UDI | Class II | Active |
| Pro-Paks | 217618H | FDA UDI | Class II | Active |
| Pro-Paks®️ | PD831 | FDA UDI | Class II | Active |
| Pro-Paks | MK-7525 | FDA UDI | Class I | Active |
| Pro-Paks | MK-7306 | FDA UDI | Class I | Active |
| Pro-Paks | 218030C | FDA UDI | Class II | Active |
| Pro-Paks | MK-7132 | FDA UDI | Class I | Active |
| Pro-Paks | 21440D | FDA UDI | Class II | Active |
| Pro-Paks | MK-7030 | FDA UDI | Class I | Active |
| Pro-Paks | MK-7826 | FDA UDI | Class I | Active |
| Pro-Paks | 221089A | FDA UDI | Class II | Active |
| Pro-Paks®️ | PD1060 | FDA UDI | Class II | Active |
| Pro-Paks | MK-7452 | FDA UDI | Class I | Active |
| Pro-Paks | MK-7720A | FDA UDI | Class I | Active |
| Pro-Paks | MK-7830 | FDA UDI | Class I | Active |
| Pro-Paks | 21433C | FDA UDI | Class II | Active |
| Pro-Paks®️ | MK-103 | FDA UDI | Class II | Active |
| Pro-Paks | 219107A | FDA UDI | Class II | Active |
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