FDA UDI
In Commercial Distribution
🇺🇸 United States
R-100
DI: 00184360000327
·
Model: 804547001
·
VOLCANO CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- R-100
- Primary DI
- 00184360000327
- Version / Model
- 804547001
- Catalog Number
- 804547001
- Company Name
- VOLCANO CORPORATION
- Labeler DUNS
- 135179237
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-12
- Public Version
- 5
- Public Version Date
- 2023-07-28
- Public Version Status
- Update
- Public Device Record Key
- 31b086f6-4147-446f-8c29-8627d17d0ff4
Device Description
R-100 Pullback Device
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47853 | Intravascular ultrasound imaging catheter extractor, reusable | A non-sterile, battery-powered, electronic device intended to slowly retract (pull back) an intravascular ultrasound imaging catheter from a coronary or peripheral artery at a controlled rate using a motor combined with an extraction mechanism. This device is used in the catheterization laboratory during intravascular assessment, e.g., for the reconstruction of a two dimensional, sagittal ultrasonic diagnostic image as the catheter is slowly extracted. Pullback lengths are around 13 cm. This device is not sterilizable and must therefore be enclosed in a sterile barrier (a bag or pouch). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00184360000327 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K962293 | 000 |