FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterishot II Kit
DI: 15055515602333
·
Model: AVM-951
·
FEMCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- Sterishot II Kit
- Primary DI
- 15055515602333
- Version / Model
- AVM-951
- Catalog Number
- AVM-951
- Company Name
- FEMCARE LIMITED
- Labeler DUNS
- 500218573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-01
- Public Version
- 4
- Public Version Date
- 2024-01-19
- Public Version Status
- Update
- Public Device Record Key
- 1165ef2c-8d91-4743-a995-d8966a682708
Device Description
Single Patient Use Filshie® Clip Application Kit for Dual Incision Laparoscopy. Includes one Sterishot II 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
- 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 |
|---|---|---|---|---|---|---|
| Previous | 15055515602180 | GS1 | ||||
| Package | 55055515602331 | GS1 | Box | 14 | Not in Commercial Distribution | 2022-02-28 |
| Primary | 15055515602333 | GS1 | ||||
| Package | 45055515602334 | GS1 | Box | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +441794525100
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P920046 | 008 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place