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Sign in to claim this brandGreatbatch Ltd
US
Last updated May 23, 2026
What Greatbatch Ltd makes
Greatbatch Ltd manufactures vascular catheter introduction sets, including peelable introducer kits designed for single-use procedures, as well as vascular guide-catheters for guiding medical instruments through blood vessels. Their portfolio also includes spinal cord stimulation systems for pain management, neurosurgical kits for non-medicated procedures, and electrical stimulation leads and adaptors for pacing, defibrillation, and neural-tissue applications. Epicardial pacing leads are among the company’s offerings for cardiac rhythm management.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class III, reflecting varying levels of risk and regulatory oversight. These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, 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
- 968623467
Catalogue (367)
Page 2 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OptiSeal™ | 1003975-012 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000092-013 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667097-303 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-024 | FDA UDI | Class II | Active |
| FasTac® Flex | 201600-006 | FDA UDI | Class I | Active |
| OptiSeal™ | 1003975-013 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-020 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 7093 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000092-006 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667127-351 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667087-303 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 7091 | FDA UDI | Class II | Active |
| RadialSeal™ Introducer Kit, SS Wire | SPC-000653-006 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000092-014 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000092-003 | FDA UDI | Class II | Active |
| RadialSeal™ Introducer Kit, Poly Wire | SPC-000654-007 | FDA UDI | Class II | Active |
| ViaPeel™ | 10893-007 | FDA UDI | Class II | Active |
| Capella™ | 1012868-005 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667133-303 | FDA UDI | Class II | Active |
| Algovita® | 4010-USA | FDA UDI | Class III | Active |
| OptiSeal™ | 1003975-004 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667129-351 | FDA UDI | Class II | Active |
| ViaPeel™ | 10893-012 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-018 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-021 | FDA UDI | Class II | Active |
| ViaPeel™ | 10893-018 | FDA UDI | N/A | Active |
| Flowguard™ | 10684-003 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667089-351 | FDA UDI | Class II | Active |
| Greatbatch Steerable Sheath | 10876-002 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667087-351 | FDA UDI | Class II | Active |
| OptiSeal™ | 1002634-013 | FDA UDI | Class II | Active |
| OptiSeal™ | 1003975-013 | FDA UDI | Class II | Active |
| Algovita® | 1081-45T-USA | FDA UDI | Class III | Active |
| PTFE Peelable Introducer Kit | 667089-402 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667096-351 | FDA UDI | Class II | Active |
| Algovita® | 5212-60-USA | FDA UDI | Class III | Active |
| Mobicath™ | D140010 | FDA UDI | Class II | Active |
| Algovita® | 4220-USA | FDA UDI | Class III | Active |
| ViaPeel™ | 10893-015 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-014 | FDA UDI | N/A | Active |
| OptiSeal™ | 1003975-009 | FDA UDI | Class II | Active |
| OptiSeal™ | 1003975-008 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-022 | FDA UDI | Class II | Active |
| OptiSeal™ | 1000093-023 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667093-402 | FDA UDI | Class II | Active |
| PTFE Peelable Introducer Kit | 667095-402 | FDA UDI | Class II | Active |
| ViaPeel™ | 10893-017 | FDA UDI | Class II | Active |
| Algovita® | 1121-60-USA | FDA UDI | Class III | Active |
| Boston Scientific Channel Steerable Sheath | M004CS200 | FDA UDI | Class II | Unknown |
| Flowguard™ | 10684-001 | FDA UDI | Class II | Active |
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