FDA UDI
In Commercial Distribution
🇺🇸 United States
IMPEDE-FX Embolization Plug
DI: 00810041650054
·
Model: IMP-FX-12
·
SHAPE MEMORY MEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- IMPEDE-FX Embolization Plug
- Primary DI
- 00810041650054
- Version / Model
- IMP-FX-12
- Catalog Number
- IMP-FX-12
- Company Name
- SHAPE MEMORY MEDICAL INC
- Labeler DUNS
- 025984823
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-02
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 97c52a32-5570-40bb-894f-211740b8a16d
Device Description
IMPEDE-FX Embolization Plug, 12mm
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
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| KRD | Device, Vascular, For Promoting Embolization | Cardiovascular | 870.3300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46852 | Extraluminal vascular occluder, single-use | A device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810041650051 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 00810041650054 | GS1 | ||||
| Previous | B054IMPFX121 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182390 | 000 |