Identity
- Trade Name
- FALOPE-RING FDA UDI
- Generic Name
- Fallopian tube clip/band FDA UDI
- Device Name
- FALOPE-RING BAND GUIDE KIT W/ 1-Band Guide, 2-Band Dilators & 6-O Rings FDA UDI
- Model / Reference
- 000879-506 FDA UDI
- Description
- FALOPE-RING BAND GUIDE KIT W/ 1-Band Guide, 2-Band Dilators & 6-O Rings FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925028869 FDA UDI
- PMA Number
- P870076 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Fallopian tube clip/band
Falope-Ring by Gyrus Acmi, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fallopian tube clip/band.
- Sterishot II Elite Kit — Femcare , Ltd. · 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
- Sterishot II Kit — Femcare , Ltd. · Class III
- Sterishot — Femcare , Ltd. · Class III
Cleared under the same submission
P870076 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 III | Pending data |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 972dd8c9-83e2-4868-bd60-dcaa3f23943b 34 fields · synced May 30, 2026