Identity
- Trade Name
- Sterrad FDA UDI
- Generic Name
- Plasma sterilizer FDA UDI
- Device Name
- Sterrad NX Sterilizer FDA UDI
- Model / Reference
- 10033 FDA UDI
- Description
- Sterrad NX Sterilizer FDA UDI
Identifiers
- Catalog Number
- 10033 FDA UDI
- Primary DI / UDI-DI
- 10705037014132 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
Sterrad by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Plasma sterilizer.
- STERILINK™ — Plasmapp Co., Ltd. · Class II
- H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
- ERYİĞİT — ERYİĞİT ENDÜSTRİYEL MAKİNA VE TIBBİ CİHAZLAR İMALAT İTHALAT İHRACAT İNŞAAT TİCARET ANONİM ŞİRKETİ · Class IIb
- P50 — SMS Sp. z o.o. · Class IIa
- STERILINK™ — Plasmapp Co., Ltd. · Class II
- H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
- H2O2 Low Temperature Plasma Sterilizer — Shinva Medical Instrument Co., Ltd. · Class IIa
- P150DD — SMS Sp. z o.o. · Class IIb
Cleared under the same submission
K042116 also covers:
K142454 also covers:
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
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
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI c2338aee-d239-4bde-9197-2b325a0af404 36 fields · synced May 30, 2026