Identity
- Trade Name
- Omni 5 Fr. Seal Cap EUDAMEDFDA UDI
- Generic Name
- Endoscope working-channel seal FDA UDI
- Device Name
- Omni Lok Cervical Seal; Omni 5Fr Seal Cap; MyoSure Single Use Seal EUDAMEDThe Omni™ 5 Fr. Seal Caps are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of the removable outflow channels. FDA UDI
- Model / Reference
- 60-5FR EUDAMEDFDA UDI
- Description
- The Omni™ 5 Fr. Seal Caps are an accessory to the Hologic Hysteroscopes and are used to prevent distension fluid leakage from the proximal ends of the removable outflow channels. FDA UDI
Identifiers
- Catalog Number
- 60-5FR FDA UDI
- Primary DI / UDI-DI
- 15420045513839 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSSCOPESEALWP EUDAMED
- Direct Marketing DI
- 15420045513839 EUDAMED
- 510(k) Number
- K142029 FDA UDI
- FDA Product Code
- HIH FDA UDI
- EMDN Code
- Z12020785 GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Endoscope working-channel seal FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Omni 5 Fr. Seal Cap by Hologic Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 54200455GSSSCOPESEALWP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
- EUDAMED SRN
- US-MF-000003310
- Authorised Representative
- Hologic BV BE-AR-000000127
Sources (2)
- EUDAMED 7b3ff03a-0df1-47c5-b048-b4adb3eb0757 61 fields · synced Jul 12, 2026
- FDA UDI a22f9730-1b6a-453b-abb8-4bb28bef05d9 36 fields · synced May 30, 2026