Identity
- Trade Name
- Puritan FDA UDI
- Generic Name
- Tongue depressor, examination, single-use FDA UDI
- Device Name
- Tongue Depressors, Sterile EUDAMEDSterile Junior Tongue Depressors FDA UDI
- Model / Reference
- 25-711 EUDAMEDFDA UDI
- Description
- Sterile Junior Tongue Depressors FDA UDI
Identifiers
- Catalog Number
- 25-711 FDA UDI
- Primary DI / UDI-DI
- 00609576370038 EUDAMEDFDA UDI
- Basic UDI-DI
- 0609576TDSEU 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tongue depressor, examination, single-use
Puritan by Puritan Medical Products Company Llc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Puritan Medical Products Company Llc
Sources (2)
- FDA UDI 4ad4ddad-8c2e-424e-8287-647378817825 35 fields · synced Jul 28, 2026
- EUDAMED a854dd08-76ec-4fcb-835a-7fac15cf8a4c 61 fields · synced Jul 28, 2026