FDA UDI
In Commercial Distribution
🇺🇸 United States
Auryon Atherectomy Catheter
DI: 07290017590318
·
Model: EXM-4011-0000
·
EXIMO MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Auryon Atherectomy Catheter
- Primary DI
- 07290017590318
- Version / Model
- EXM-4011-0000
- Catalog Number
- EXM-4011-0000
- Company Name
- EXIMO MEDICAL LTD
- Labeler DUNS
- 600468941
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-28
- Public Version
- 1
- Public Version Date
- 2024-01-05
- Public Version Status
- New
- Public Device Record Key
- 69e57e4e-dbe8-493b-bbb0-56954a6bfdd0
Device Description
Auryon Atherectomy Catheter 0.9mm Longer Length (XL) OTW
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
- 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 | 07290017590318 | GS1 |
Customer Contacts
- Phone
- (518) 795-1676
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233668 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.9 | Millimeter | |
| Length | 225 | Centimeter | |
| Lumen/Inner Diameter | 0.014 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 60 Degrees Celsius