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STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 10104-009Model 10104
Identity
- Trade Name
- STERRAD™ 100NX, Systems with ALLClear™ Technology, 1 Door with ULTRA GI™ cycle EUDAMEDSTERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle FDA UDI
- Generic Name
- Plasma sterilizer FDA UDI
- Device Name
- STERRAD™ 100NX Sterilizer with ALLClear™ Technology EUDAMEDPlasma Sterilizer FDA UDI
- Model / Reference
- 10104-009 EUDAMEDFDA UDI10104 EUDAMED
- Description
- Plasma Sterilizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10705037068425 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A050000000000005NU EUDAMED
- Direct Marketing DI
- 10705037068425 EUDAMED
- 510(k) Number
- K234082 FDA UDI
- FDA Product Code
- MLR FDA UDI
- EMDN Code
- Z12011309 PLASMA STERILISERS EUDAMED
- GMDN Term
- Plasma sterilizer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Plasma sterilizer
STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID…
Similar devices
Also classified as Plasma sterilizer.
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- 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
K234082 also covers:
- Aptimax Instrument TRAY for ULTRA GI Cycle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ULTRA GI Cycle Validation Kit — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 6244eb59-7ad9-4ddf-8739-a14a7c927457 36 fields · synced Jul 17, 2026
- EUDAMED e18b0876-0713-4139-8a4d-0fa3fb453ed4 61 fields · synced Jul 17, 2026