Identity
- Trade Name
- Omni Instrument Tray FDA UDI
- Generic Name
- Rigid optical hysteroscope FDA UDI
- Model / Reference
- 60-903 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15420045510296 FDA UDI
- 510(k) Number
- K182052 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Rigid optical hysteroscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 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
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical hysteroscope
Omni Instrument Tray by Hologic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical hysteroscope.
- TruClear — Covidien LP · Class II
- BR Surgical, LLC — BR SURGICAL LLC · Class II
- TRUCLEAR — Smith & Nephew, Inc. · Class II
- Hysteroscope — SOPRO-COMEG GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- Gimmi — Gimmi GmbH · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
Cleared under the same submission
K182052 also covers:
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
- Hologic, Inc.
Sources (1)
- FDA UDI 61c197b0-a93b-4e9e-92c5-a04bf7ac8903 33 fields · synced May 30, 2026