Tongue depressor, Wuerzburg type
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Tongue depressor, Wuerzburg type FDA UDI
- Generic Name
- Tongue depressor, surgical FDA UDI
- Device Name
- Spatulas EUDAMEDsize 4, 37 x 96 mm FDA UDI
- Model / Reference
- 40-320-04 EUDAMEDFDA UDI
- Description
- size 4, 37 x 96 mm FDA UDI
Identifiers
- Catalog Number
- 40-320-04 FDA UDI
- Primary DI / UDI-DI
- 04250381885734 EUDAMEDFDA UDI
- Basic UDI-DI
- 425038185G0501S2 EUDAMED
- Direct Marketing DI
- 04250381885734 EUDAMED
- FDA Product Code
- KBL FDA UDI
- EMDN Code
- L14010205 OROPHARYNGAL SURGERY DEPRESSORS, REUSABLE EUDAMED
- GMDN Term
- Tongue depressor, surgical FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Tongue depressor, surgical
Tongue depressor, Wuerzburg type by Spiggle & Theis Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Spiggle & Theis Medizintechnik GmbH
Sources (2)
- FDA UDI b78f9998-1874-42ee-9472-66fac9c625fa 35 fields · synced Oct 7, 2026
- EUDAMED 5b4da1a6-1c0a-4294-aebf-d334c27f18f0 61 fields · synced Oct 7, 2026