Identity
- Trade Name
- CHELSEA-EATON SPECULUM FDA UDI
- Generic Name
- Rectal speculum FDA UDI
- Device Name
- CHELSEA-EATON SPECULUM LARGE TUBE SLOTTED HANDLE FDA UDI
- Model / Reference
- 508-354 FDA UDI
- Description
- CHELSEA-EATON SPECULUM LARGE TUBE SLOTTED HANDLE FDA UDI
Identifiers
- Catalog Number
- 508-354 FDA UDI
- Primary DI / UDI-DI
- 00192896044531 FDA UDI
- FDA Product Code
- FFQ FDA UDI
- GMDN Term
- Rectal speculum FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
Category: Rectal speculum
Chelsea-Eaton Speculum 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 01ee0289-7fed-4f5a-882a-0ebfc0cf91ab 35 fields · synced May 30, 2026