FDA UDI
In Commercial Distribution
🇺🇸 United States
Penumbra System
DI: M424DH10
·
Model: DH1
·
PENUMBRA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Penumbra System
- Primary DI
- M424DH10
- Version / Model
- DH1
- 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
- b7dedc8e-6608-4714-9eaa-75c222893b37
Device Description
DH1 Bundle of 5
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
- Labeling does not contain MRI Safety Information
- 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 | M424DH10 | HIBCC | ||||
| Secondary | 00814548011974 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103305 | 000 |