Identity
- Trade Name
- Wooden Tongue Depressor EUDAMEDInstrapac FDA UDI
- Generic Name
- Tongue depressor, examination, single-use FDA UDI
- Device Name
- Wooden Tongue Depressor EUDAMEDInstrapac Wooden Tongue Depressors X 5,000 (50 boxes of 100) FDA UDI
- Model / Reference
- 8360 EUDAMEDFDA UDI
- Description
- Instrapac Wooden Tongue Depressors X 5,000 (50 boxes of 100) FDA UDI
Identifiers
- Catalog Number
- 8360 FDA UDI
- Primary DI / UDI-DI
- 05010058083608 EUDAMEDFDA UDI
- Basic UDI-DI
- 5010058C01nT025G00A27 EUDAMED
- FDA Product Code
- FMA FDA UDI
- EMDN Code
- V9001 TONGUE DEPRESSORS, SINGLE-USE EUDAMED
- GMDN Term
- Tongue depressor, examination, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6230 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Wooden Tongue Depressor by Robinson Healthcare Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5010058C01nT025G00A27 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Robinson Healthcare Ltd
- EUDAMED SRN
- GB-MF-000016546
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED b5746f85-b371-4a22-8660-df2573ec3fb2 61 fields · synced Jun 18, 2026
- FDA UDI b69097f0-74db-47c8-9c7a-549b05a923cb 36 fields · synced May 26, 2026