FDA UDI
In Commercial Distribution
🇺🇸 United States
Filshie® Clips (Femcare)
DI: 25055515602248
·
Model: AVM-851J
·
FEMCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
2
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Filshie® Clips (Femcare)
- Primary DI
- 25055515602248
- Version / Model
- AVM-851J
- Catalog Number
- AVM-851J
- Company Name
- FEMCARE LIMITED
- Labeler DUNS
- 500218573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-02-28
- Public Version
- 1
- Public Version Date
- 2025-03-10
- Public Version Status
- New
- Public Device Record Key
- fe9ad19d-be21-4f8e-a1c8-455f52ce5250
Device Description
The Filshie Tubal Ligation System - Filshie Clips for permanent female sterilization by occlusion of the Fallopian tubes.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNH | Device, Occlusion, Tubal, Contraceptive | Obstetrics/Gynecology | 884.5380 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33598 | Fallopian tube clip/band | An implantable device applied externally to the fallopian tube(s) to constrict the tube and prevent the passage of ova. It is typically used during tubal ligation procedures and functions as a contraceptive device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05055515602244 | GS1 | ||||
| Primary | 25055515602248 | GS1 | ||||
| Package | 45055515602242 | GS1 | Box | 10 | In Commercial Distribution | |
| Package | 65055515602246 | GS1 | Overpack | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- +441794525100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P920046 | 000 |
| P920046 | 014 |