FDA UDI
In Commercial Distribution
🇺🇸 United States
Turbo Tandem™
DI: 00813132020255
·
Model: 482-110AA
·
Spectranetics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Turbo Tandem™
- Primary DI
- 00813132020255
- Version / Model
- 482-110AA
- Catalog Number
- 482-110
- Company Name
- Spectranetics Corporation
- Labeler DUNS
- 151047370
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-02-06
- Public Version
- 4
- Public Version Date
- 2021-10-26
- Public Version Status
- Update
- Public Device Record Key
- 968f0475-10de-4d84-9775-a119b60bef92
Device Description
Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|---|---|
| Secondary | M204482110AA0 | HIBCC | ||||
| Primary | 00813132020255 | GS1 |
Customer Contacts
- Phone
- 1-800-633-0960
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 110 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit