Identity
- Trade Name
- CLEFT PALATE ELEVATOR FDA UDI
- Generic Name
- ENT elevator FDA UDI
- Device Name
- CLEFT PALATE ELEVATOR DOUBLE ENDED BLADES FDA UDI
- Model / Reference
- 478-395 FDA UDI
- Description
- CLEFT PALATE ELEVATOR DOUBLE ENDED BLADES FDA UDI
Identifiers
- Catalog Number
- 478-395 FDA UDI
- Primary DI / UDI-DI
- 00192896043534 FDA UDI
- FDA Product Code
- KAD FDA UDI
- GMDN Term
- ENT elevator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 6.25 Inch FDA UDI
Category: ENT elevator
Cleft Palate Elevator by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 4b03d1c6-5742-409f-87c1-74bce378004f 36 fields · synced Jun 8, 2026