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STATIM 5000 Cassette Autoclave
FDA UDIFDA 510(k)Class II (US FDA UDI)
510(k) K983679
by Scican GmbH
Identity
- Trade Name
- STATIM 5000 Cassette Autoclave FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Table-top steam sterilizer with removable cassette sterilization chamber (Loaner) FDA UDI
- Model / Reference
- 01-201104-L FDA UDI
- Description
- Table-top steam sterilizer with removable cassette sterilization chamber (Loaner) FDA UDI
Identifiers
- Catalog Number
- 01-201104-L FDA UDI
- Primary DI / UDI-DI
- 07540196001243 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 FDA UDI
- Commercial Distribution
- Not 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
No
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
STATIM 5000 Cassette Autoclave by Scican GmbH — Class II — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962179 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K983679 | Class II | Active |
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Manufacturer
- Manufacturer
- Scican GmbH
- FDA Applicant
- Scican
Sources (2)
- FDA UDI b57d5100-a8cc-4360-8f20-bec18d2c4127 60 fields · synced Jun 18, 2026
- FDA 510(k) K962179 1 fields · synced Jun 4, 2026