FDA UDI
In Commercial Distribution
🇺🇸 United States
POD
DI: M424RBYPOD40
·
Model: RBYPOD4
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- POD
- Primary DI
- M424RBYPOD40
- Version / Model
- RBYPOD4
- Company Name
- PENUMBRA, INC.
- Labeler DUNS
- 191077671
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 09ef3e01-940b-4eb3-87b7-a719244724a2
Device Description
POD Cplx, 4x30
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| HCG | DEVICE, NEUROVASCULAR EMBOLIZATION | Neurology | 882.5950 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43980 | Embolization implant kit | A collection of sterile devices and supplies used in combination for the implantation of an embolization implant that will purposely create permanent or temporary obstruction, i.e., stop the flow of blood, in arteries/blood vessels. The kit will typically consist of, e.g., an embolization implant, an inserter, a dedicated syringe, and possibly other supplies necessary for the surgical procedure. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M424RBYPOD40 | HIBCC | ||||
| Secondary | 00814548013756 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141134 | 000 |