FDA UDI
In Commercial Distribution
🇺🇸 United States
Dragonfly™ OPTIS™
DI: 00183739000654
·
Model: C408646
·
LIGHTLAB IMAGING, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dragonfly™ OPTIS™
- Primary DI
- 00183739000654
- Version / Model
- C408646
- Catalog Number
- C408646
- Company Name
- LIGHTLAB IMAGING, INC.
- Labeler DUNS
- 018493531
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-04-20
- Public Version
- 4
- Public Version Date
- 2023-10-02
- Public Version Status
- Update
- Public Device Record Key
- 32d9401f-4f7f-4487-95a9-20140ba0fe0e
Device Description
Imaging Catheter Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC | Cardiovascular | 870.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47491 | Coronary optical coherence tomography system catheter | A sterile flexible tube with an extremely fine working end that houses an optical fibre and imaging lens intended to be transcutaneously introduced into the coronary vasculature to perform coronary optical coherence tomography (OCT). The proximal end of the device connects to a coronary OCT console for the transmission of high-resolution images (e.g., 5 to 40 micron) of the coronary intravasculature. It is typically made of stainless steel, plastic, and optical materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00183739000654 | GS1 |
Customer Contacts
- Phone
- +1(855)478-5833
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 2.7 | French |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- STORE IN A DARK, DRY PLACE