Identity
- Trade Name
- SONTEC BLACK CASE FDA UDI
- Generic Name
- General physical examination set FDA UDI
- Device Name
- SONTEC BLACK CASE FDA UDI
- Model / Reference
- C-079.05.000 FDA UDI
- Description
- SONTEC BLACK CASE FDA UDI
Identifiers
- Catalog Number
- C-079.05.000 FDA UDI
- Primary DI / UDI-DI
- 00192896071629 FDA UDI
- FDA Product Code
- ETF FDA UDI
- GMDN Term
- General physical examination set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.5300 FDA UDI
- Commercial Distribution
- Not 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
- Width — 13 Inch FDA UDILength — 16.25 Inch FDA UDIHeight — 6 Inch FDA UDI
Sontec Black Case by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 80c1236f-41e5-4a2d-ba0e-47293d809456 37 fields · synced May 31, 2026