Identity
- Trade Name
- IMPEDE Embolization Plug FDA UDI
- Generic Name
- Extraluminal vascular occluder, single-use FDA UDI
- Device Name
- IMPEDE Embolization Plug 10mm FDA UDI
- Model / Reference
- IMP-10 FDA UDI
- Description
- IMPEDE Embolization Plug 10mm FDA UDI
Identifiers
- Catalog Number
- IMP-10 FDA UDI
- Primary DI / UDI-DI
- B054IMP101 FDA UDI
- 510(k) Number
- K181051 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Extraluminal vascular occluder, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
IMPEDE Embolization Plug by Shape Memory Medical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shape Memory Medical Inc
Sources (1)
- FDA UDI 2a852979-29f2-47a2-8d02-c3f00e972a8b 36 fields · synced Jun 9, 2026