Identity
- Trade Name
- SCT 2000 FDA UDI
- Generic Name
- Bathing/changing table, stationary FDA UDI
- Device Name
- SCT 2000 shower table, outer measurements 35.4'' x 70.9'', lying surface in mesh cover, 21.7'' x 65'', white. With safety rail and water collection tray, foldable, electrically height adjustable with wired remote control, wall-mounted FDA UDI
- Model / Reference
- R8591218 FDA UDI
- Description
- SCT 2000 shower table, outer measurements 35.4'' x 70.9'', lying surface in mesh cover, 21.7'' x 65'', white. With safety rail and water collection tray, foldable, electrically height adjustable with wired remote control, wall-mounted FDA UDI
Identifiers
- Catalog Number
- R8591218000 FDA UDI
- Primary DI / UDI-DI
- 05708590376127 FDA UDI
- FDA Product Code
- INQ FDA UDI
- GMDN Term
- Bathing/changing table, stationary FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3760 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Bathing/changing table, stationary
Sct 2000 by Pressalit A/S — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Pressalit A/S
Sources (1)
- FDA UDI 9d272a35-0bca-4652-b572-82d4d1caa0c0 35 fields · synced May 30, 2026