Identity
- Trade Name
- Benesta Hysteroscope Adapter FDA UDI
- Generic Name
- Endoscope working-channel proximal spacer FDA UDI
- Device Name
- The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysteroscopes and the Benesta Tissue Removal Device (TRD) to properly position the TRD while in use. FDA UDI
- Model / Reference
- CAL-TR1431 FDA UDI
- Description
- The Benesta Hysteroscope Adapter is placed between non-Caldera Medical hysteroscopes and the Benesta Tissue Removal Device (TRD) to properly position the TRD while in use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857492008164 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Endoscope working-channel proximal spacer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscope working-channel proximal spacer
Benesta Hysteroscope Adapter by Caldera Medical, Inc. — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Caldera Medical, Inc.
Sources (1)
- FDA UDI f1b54db2-159d-457c-82a4-9c2beaa865ec 35 fields · synced Jun 8, 2026