FDA UDI
In Commercial Distribution
🇺🇸 United States
ELCA™
DI: 00813132020040
·
Model: 114-009AA
·
Spectranetics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ELCA™
- Primary DI
- 00813132020040
- Version / Model
- 114-009AA
- Catalog Number
- 114-009
- 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
- d2a94a88-afc5-40d4-b095-717607afd22b
Device Description
ELCA™ Coronary 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 |
|---|---|---|---|---|
| LPC | Device, Angioplasty, Laser, Coronary | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17185 | Atherectomy laser system beam guide-catheter, coronary | A sterile, flexible tube intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the coronary arteries for the ablation of atherosclerotic plaques in completely occluded vessels. It typically consists of fibreoptic materials with a laser-firing distal end and allows the treatment to be made without significant thermal effect. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | M204114009AA0 | HIBCC | ||||
| Primary | 00813132020040 | GS1 |
Customer Contacts
- Phone
- 1-800-633-0960
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P910001 | 014 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 1.45 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit