FDA UDI
In Commercial Distribution
🇺🇸 United States
PulseRider
DI: 00859030005253
·
Model: PRDSCBD
·
Medos International Sàrl
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PulseRider
- Primary DI
- 00859030005253
- Version / Model
- PRDSCBD
- Catalog Number
- PRDSCBD
- Company Name
- Medos International Sàrl
- Labeler DUNS
- 482661753
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-17
- Public Version
- 5
- Public Version Date
- 2023-05-03
- Public Version Status
- Update
- Public Device Record Key
- ad46678e-bdeb-40e7-96e0-5c009d635de5
Device Description
PulseRider Aneurysm Neck Reconstruction Device Detachment System Controller
Device Characteristics
- Single Use
- No
- 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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NJE | Intracranial Neurovascular Stent | Unknown | f |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61754 | Vascular implant detacher, electronic, reusable | A noninvasive, hand-held, electrically-powered unit intended to deliver a low-level electric current to break the connection between a vascular implantable device (typically a neurovascular or peripheral embolization coil or stent) and its deployment device (i.e., implant inserter or delivery wire) via an electrolytic reaction. It is intended to connect to the proximal end of an appropriate implant inserter (delivery wire) which conducts the current to the electrically-unstable detachment point. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859030005253 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| H160002 | 000 |
| H160002 | 002 |
| H160002 | 008 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 104 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius