Identity
- Trade Name
- Omni Lok Cervical Seal EUDAMEDCERVICAL SEAL ASSY DEVICE FDA UDI
- Generic Name
- Hysteroscopy cervical leakage sheath FDA UDI
- Device Name
- Omni Lok Cervical Seal; Omni 5Fr Seal Cap; MyoSure Single Use Seal EUDAMEDThe Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix. FDA UDI
- Model / Reference
- OLK-100 EUDAMEDFDA UDI
- Description
- The Omni™ Lok cervical seal is used during a hysteroscopic procedure to minimize liquid distention media leakage from the cervix. FDA UDI
Identifiers
- Catalog Number
- OLK-100 FDA UDI
- Primary DI / UDI-DI
- 15420045512191 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455GSSSCOPESEALWP EUDAMED
- Direct Marketing DI
- 15420045512191 EUDAMED
- 510(k) Number
- K191281 FDA UDI
- FDA Product Code
- QHZ FDA UDI
- EMDN Code
- Z12020785 GENITOURINARY ENDOSCOPY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Hysteroscopy cervical leakage sheath FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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 Lok Cervical Seal 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 06c1a768-9d88-4d36-a7c5-a6dcd26e681a 61 fields · synced Jul 16, 2026
- FDA UDI c6c8ae82-f032-4589-acfc-9d3edf180c11 36 fields · synced May 30, 2026