Identity
- Trade Name
- McCarus-Volker FORNISEE® SYSTEM FDA UDI
- Generic Name
- Uterine sound, reusable FDA UDI
- Device Name
- 12cm FS® SOUND - SINGLE FDA UDI
- Model / Reference
- 110106 FDA UDI
- Description
- 12cm FS® SOUND - SINGLE FDA UDI
Identifiers
- Catalog Number
- 110106 FDA UDI
- Primary DI / UDI-DI
- 00850200006384 FDA UDI
- 510(k) Number
- K111014 FDA UDI
- FDA Product Code
- LKF FDA UDI
- GMDN Term
- Uterine sound, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.4530 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
No
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 — 12 Centimeter FDA UDI
Category: Uterine sound, reusable
McCarus-Volker FORNISEE® SYSTEM by LSI Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Uterine sound, reusable.
- HNM Medical — HNM STAINLESS, LLC. · Class I
- Sims Uterine Sound — CooperSurgical, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- HNM Medical — HNM STAINLESS, LLC. · Class I
- American Medicals — AMERICAN MEDICALS · Class I
- AESCULAP — AESCULAP, INC. · Class I
- SIMS SOUND — SONTEC INSTRUMENTS, INC. · Class I
Cleared under the same submission
K111014 also covers:
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
- McCarus-Volker FORNISEE® SYSTEM — LSI Solutions, Inc.
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
- LSI Solutions, Inc.
Sources (1)
- FDA UDI 5755f8a7-e597-4b57-978e-baabd1de7854 37 fields · synced May 31, 2026