FDA UDI
In Commercial Distribution
🇺🇸 United States
CP Stent™
DI: 04046964899591
·
Model: 614379
·
B BRAUN INTERVENTIONAL SYSTEMS, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CP Stent™
- Primary DI
- 04046964899591
- Version / Model
- 614379
- Catalog Number
- 614379
- Company Name
- B BRAUN INTERVENTIONAL SYSTEMS, INC
- Labeler DUNS
- 784259751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-19
- Public Version
- 8
- Public Version Date
- 2025-04-18
- Public Version Status
- Update
- Public Device Record Key
- 6da28aa1-5f91-44bd-9c95-8e7b632e3239
Device Description
CMCP030 Mounted Covered CP Stent 4.5 16
Device Characteristics
- Single Use
- Yes
- 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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| PNF | Aortic stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48060 | Descending thoracic aorta endovascular stent-graft | A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]; it is not intended for implantation within the aortic arch. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04046964899591 | GS1 |
Customer Contacts
- Phone
- +1(877)836-2228
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150028 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter (mm) : 16.000 MM | ||
| Device Size Text, specify | Length : 45.000 MM |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 45 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- KEEP AWAY FROM SUNLIGHT
- Type
- Special Storage Condition, Specify