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Sign in to claim this brandGolnit Sutures
US
Last updated May 27, 2026
What Golnit Sutures makes
The company manufactures sutures made from polytetrafluoroethylene (PTFE) and nylon, including both monofilament and multifilament variants. These products are designed for surgical applications requiring durable, tissue-friendly materials for wound closure. The PTFE sutures are intended for use in general soft tissue approximation, while the nylon monofilament sutures are suited for applications where minimal tissue reactivity is critical. All listed sutures are formulated to provide strength and flexibility for various surgical procedures.
The suture portfolio is classified under Class II devices in the US regulatory framework and is listed in the FDA Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable US regulatory standards for medical device authorisation. No other regulatory jurisdictions or registries are referenced in the available data.
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 Golnit Sutures manufacture?
Golnit Sutures specializes in surgical sutures made from polytetrafluoroethylene (PTFE) and nylon. Their portfolio includes both monofilament and multifilament sutures, designed for wound closure in surgical procedures. PTFE sutures are typically used for general soft tissue approximation, while nylon monofilament sutures are ideal for applications requiring minimal tissue reactivity.
Where is Golnit Sutures based, and what regulatory standards does it follow?
Golnit Sutures is based in the United States. The company adheres to applicable US regulatory standards for medical device authorisation, ensuring compliance with the regulatory framework governing Class II devices in the country.
Which regulatory registries list Golnit Sutures’ devices?
Golnit Sutures’ devices are listed in the FDA Unique Device Identifier (UDI) database. This registry ensures traceability and identification of medical devices under US regulatory oversight. No other registries or jurisdictions are referenced for this manufacturer in the available data.
How are Golnit Sutures’ devices classified under US regulations?
Golnit Sutures’ products fall under Class II device classification in the US regulatory framework. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as sutures used in surgical wound closure.
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
- 079932697
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Golnit PTFE Suture | mTH601333-45 | FDA UDI | Class II | Active |
| Golnit PTFE Sutures | mRD401853-45 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | mTH401343-45 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D5018-75 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D4016-75 | FDA UDI | Class II | Active |
| Golnit PTFE Sutures | mRD401648-45 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | mRD601338-45 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D5016-75 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | mRD501643-45 | FDA UDI | Class II | Active |
| Golnit PTFE Sutures | mRD301956-45 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | FTD501324d-75 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | mRD501343-45 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D3019-75 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D4018-75 | FDA UDI | Class II | Active |
| Golnit Nylon Monofilament Suture | NB2D6016-75 | FDA UDI | Class II | Active |
| Golnit PTFE Suture | mTH501333-45 | FDA UDI | Class II | Active |
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