FDA UDI
In Commercial Distribution
🇺🇸 United States
CROSSTELLA RX
DI: 04540778158436
·
Model: BD-F25200MR
·
KANEKA CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CROSSTELLA RX
- Primary DI
- 04540778158436
- Version / Model
- BD-F25200MR
- Catalog Number
- BD-F25200MR
- Company Name
- KANEKA CORPORATION
- Labeler DUNS
- 690535406
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-26
- Public Version
- 4
- Public Version Date
- 2019-08-09
- Public Version Status
- Update
- Public Device Record Key
- e809e03e-81f7-42f0-96c1-cb4ac6bc97a2
Device Description
CROSSTELLA RX is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter for peripheral indications. CROSSTELLA RX is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.018 inches (0.46mm).
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
- 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 |
|---|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17184 | Peripheral angioplasty balloon catheter, basic | A sterile, non-drug-eluting, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single lumen. Some types may include cutting/scoring elements (e.g., microsurgical blades, dual wire configurations) to score/modify the plaque. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04540778158436 | GS1 |
Customer Contacts
- Phone
- 800-888-3786
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152873 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Maximum Guidewire Diameter; 0.018 inch | ||
| Device Size Text, specify | Compatible Sheath Diameter; 4 Fr | ||
| Device Size Text, specify | Rated Burst Pressure; 14 atm | ||
| Device Size Text, specify | Nominal Pressure; 8 atm | ||
| Device Size Text, specify | Proximal Shaft Diameter; 3.4 Fr | ||
| Device Size Text, specify | Distal Shaft Diameter; 4.0 Fr | ||
| Device Size Text, specify | Catheter Working Length; 900 mm | ||
| Device Size Text, specify | Balloon Length; 200 mm | ||
| Device Size Text, specify | Balloon Diameter; 2.5 mm |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry, dark place. Avoid exposure to water, direct sunlight.