Identity
- Trade Name
- GETINGE 46-SERIES FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- WASHER DISINFECTOR 46-5 D+W D, D+W D indicating double door machine with dryer. Cat no was 46-5-403. From March 2019 new cat no is 46-5-503. FDA UDI
- Model / Reference
- 46-5 FDA UDI
- Description
- WASHER DISINFECTOR 46-5 D+W D, D+W D indicating double door machine with dryer. Cat no was 46-5-403. From March 2019 new cat no is 46-5-503. FDA UDI
Identifiers
- Catalog Number
- 46-5-503 FDA UDI
- Primary DI / UDI-DI
- 07340153700086 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical utensil washer/disinfector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
Getinge 46-Series by Getinge Disinfection, Inc. — 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
- Getinge Disinfection, Inc.
Sources (1)
- FDA UDI b2903f3d-b4d2-4bb1-816d-f54fc10200c6 34 fields · synced Jun 8, 2026