Identity
- Trade Name
- Sterishot II Elite Kit FDA UDI
- Generic Name
- Fallopian tube clip/band FDA UDI
- Device Name
- Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® Clips. FDA UDI
- Model / Reference
- AVM-954 FDA UDI
- Description
- Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II Applicator, 8mm Bladeless Trocar and one pair of Filshie® Clips. FDA UDI
Identifiers
- Catalog Number
- AVM-954 FDA UDI
- Primary DI / UDI-DI
- 15055515602371 FDA UDI
- PMA Number
- P920046 FDA UDI
- FDA Product Code
- KNH FDA UDI
- GMDN Term
- Fallopian tube clip/band FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Regulation Number
- 884.5380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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: Fallopian tube clip/band
Sterishot II Elite Kit by Femcare , Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fallopian tube clip/band.
- Gyrus ACMI — Gyrus Acmi, Inc. · Class III
- FALOPE-RING — Gyrus Acmi, Inc. · Class III
- FALOPE-RING — Gyrus Acmi, Inc. · Class III
- Sterishot (Femcare) for Minilaparotomy — Femcare , Ltd. · Class III
- Filshie® Clip Applicator, 5mm SI (Femcare) — Femcare , Ltd. · Class III
- Filshie® Clips (Femcare) — Femcare , Ltd. · Class III
- Filshie® Clip Applicator, 7.3mm SI (Femcare) — Femcare , Ltd. · Class III
- Sterishot (Femcare) for Minilaparotomy — Femcare , Ltd. · Class III
Cleared under the same submission
P920046 also covers:
- Filshie® Clip Applicator, 5mm SI (Femcare) — Femcare , Ltd.
- Filshie® Clip Applicator, 7.3mm SI (Femcare) — Femcare , Ltd.
- Filshie® Clip Applicator, 7.3mm Single Incision — Femcare , Ltd.
- Filshie® Clip Applicator, 7mm DI (Femcare) — Femcare , Ltd.
- Filshie® Clip Applicator, Minilap (Femcare) — Femcare , Ltd.
- Filshie® Clips — Femcare , Ltd.
- Filshie® Clips — Femcare , Ltd.
- Filshie® Clips (Femcare) — Femcare , Ltd.
- Filshie® Clips (Femcare) — Femcare , Ltd.
- Sterishot — Femcare , Ltd.
- Sterishot (Femcare) for Minilaparotomy — Femcare , Ltd.
- Sterishot (Femcare) for Minilaparotomy — Femcare , Ltd.
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 III | Pending data |
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Manufacturer
- Manufacturer
- Femcare , Ltd.
Sources (1)
- FDA UDI b0fe989d-01b1-432d-ad8f-012a4b95ea7b 37 fields · synced Jun 8, 2026