FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sterishot Kit for Minilaparotomy (CSI)
DI: 15055515602197
·
Model: AVM-951M
·
FEMCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Sterishot Kit for Minilaparotomy (CSI)
- Primary DI
- 15055515602197
- Version / Model
- AVM-951M
- Catalog Number
- AVM-951M
- Company Name
- FEMCARE LIMITED
- Labeler DUNS
- 500218573
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-06
- Public Version
- 3
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- fc42fb57-f8b7-4af9-99a6-d76406cf9aed
- Distribution End Date
- 2022-06-30
Device Description
Single Patient Use Filshie® Clip Application Kit for Minilaparotomy. Includes one Sterishot Minilap Applicator and one pair of Filshie® Clips.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|---|---|
| Package | 25055515602194 | GS1 | Overpack | 10 | Not in Commercial Distribution | 2022-06-30 |
| Primary | 15055515602197 | GS1 |
Customer Contacts
- Phone
- +441794525100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P920046 | 010 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place