Identity
- Trade Name
- STERILINK™ FDA UDI
- Generic Name
- Plasma sterilizer FDA UDI
- Device Name
- The STERLINK plus with STERPACK plus sterilization is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK plus can sterilize: 1.Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors 2.Medical devices with a single stainless-steel lumen with: - STERPACK plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter - STERLOAD: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter FDA UDI
- Model / Reference
- 110V FDA UDI
- Description
- The STERLINK plus with STERPACK plus sterilization is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture. The STERLINK plus can sterilize: 1.Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors 2.Medical devices with a single stainless-steel lumen with: - STERPACK plus: An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter - STERLOAD: An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800066500306 FDA UDI
- 510(k) Number
- K223015 FDA UDI
- FDA Product Code
- MLR FDA UDI
- GMDN Term
- Plasma sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Plasma sterilizer
Sterilink™ by Plasmapp Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Plasmapp Co., Ltd.
Sources (1)
- FDA UDI c41d4b4d-1290-444c-93b7-b6752e4e05b2 34 fields · synced Jun 8, 2026