FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Filshie® Clips (Femcare)
DI: 15055515602234
·
Model: AVM-851
·
FEMCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Filshie® Clips (Femcare)
- Primary DI
- 15055515602234
- Version / Model
- AVM-851
- Catalog Number
- AVM-851
- Company Name
- FEMCARE LIMITED
- Labeler DUNS
- 500218573
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-01
- Public Version
- 3
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- 858da85a-2f56-452e-9576-f99d5c9e5ff8
- Distribution End Date
- 2021-03-22
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
- No
- 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 |
|---|---|---|---|---|---|---|
| Previous | 05055515602121 | GS1 | ||||
| Package | 55055515602232 | GS1 | Overpack | 10 | Not in Commercial Distribution | 2021-03-22 |
| Package | 35055515602238 | GS1 | Carton | 20 | Not in Commercial Distribution | 2021-03-22 |
| Primary | 15055515602234 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P920046 | 000 |