Identity
- Trade Name
- Puritan FDA UDI
- Generic Name
- Tongue depressor, examination, single-use FDA UDI
- Device Name
- Tongue Depressors, Sterile EUDAMEDSterile Infant Tongue Depressors FDA UDI
- Model / Reference
- 25-705 EUDAMEDFDA UDI
- Description
- Sterile Infant Tongue Depressors FDA UDI
Identifiers
- Catalog Number
- 25-705 FDA UDI
- Primary DI / UDI-DI
- 00609576370021 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
- Austria 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 c5d1e1b9-d72a-4b11-bc52-d6b3cf06c3da 35 fields · synced Jun 19, 2026
- EUDAMED 38651b57-8680-4b0a-8a92-d4ad8b239cc0 61 fields · synced Jun 19, 2026