FDA UDI
In Commercial Distribution
🇺🇸 United States
Turbo-Power Laser Atherectomy Catheter
DI: 00810060550809
·
Model: 423-050
·
Philips Image Guided Therapy Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Turbo-Power Laser Atherectomy Catheter
- Primary DI
- 00810060550809
- Version / Model
- 423-050
- Catalog Number
- 423-050
- Company Name
- Philips Image Guided Therapy Corporation
- Labeler DUNS
- 118354223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-10-21
- Public Version
- 1
- Public Version Date
- 2025-10-29
- Public Version Status
- New
- Public Device Record Key
- 6919031c-3e5e-4aa2-8fec-e5d35e392ebd
Device Description
Turbo-Power Laser Atherectomy Catheter, 2.3mm
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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | Cardiovascular | 870.4875 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43229 | Atherectomy laser system beam guide-catheter, peripheral | A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the peripheral vasculature for the intraluminal photoablation or debulking of lesion material (blockages or total occlusions), to re-establish blood flow within the vessel. It typically consists of fibreoptic materials with a laser-firing distal end and may be designed for over-the-wire (OTW) or rapid exchange insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810060550809 | GS1 |
Customer Contacts
- Phone
- (800) 228-4728
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222837 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Tip Outer Diameter: 2.3 Millimeter | ||
| Device Size Text, specify | Guidewire Compatibility: 0.018 Inch | ||
| Catheter Working Length | 125 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 32 – 140 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 11 – 111 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight