Identity
- Trade Name
- POD FDA UDI
- Generic Name
- Embolization implant kit FDA UDI
- Device Name
- POD, 10x60 FDA UDI
- Model / Reference
- RBYPOD10-A FDA UDI
- Description
- POD, 10x60 FDA UDI
Identifiers
- Catalog Number
- RBYPOD10 FDA UDI
- Primary DI / UDI-DI
- 00814548019659 FDA UDI
- 510(k) Number
- K173614 FDA UDI
- FDA Product Code
- KRD FDA UDI
- GMDN Term
- Embolization implant kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3300 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Embolization implant kit
Pod by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Embolization implant kit.
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- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
Cleared under the same submission
K173614 also covers:
- POD — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
- Penumbra Coil 400 — PENUMBRA, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA UDI d45d3be9-6a76-4a3d-b197-219a94bbd983 35 fields · synced May 30, 2026