Identity
- Trade Name
- CRANEX 3D PAT POSIT ACCESSORIES FDA UDI
- Generic Name
- Seizure bite block FDA UDI
- Model / Reference
- 207623 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06430035874422 FDA UDI
- 510(k) Number
- K133544 FDA UDI
- FDA Product Code
- EHA FDA UDI
- GMDN Term
- Seizure bite block FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.1820 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Seizure bite block
Cranex 3d Pat Posit Accessories by PaloDEx Group Oy — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K133544 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
Sources (1)
- FDA UDI 36bcb333-eb90-411f-bac3-5da20c25b45f 33 fields · synced May 29, 2026