Micro Rx
Basic Information
- Brand Name
- Micro Rx
- Primary DI
- 08718481740354
- Version / Model
- RX135
- Catalog Number
- RX135
- Company Name
- IMDS Operations B.V.
- Labeler DUNS
- 489997508
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-19
- Public Version
- 2
- Public Version Date
- 2023-12-28
- Public Version Status
- Update
- Public Device Record Key
- 9b6a777d-3bca-46b9-b51c-0d661cee89f6
Device Description
The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronary and/ or peripheral vasculature. The Micro Rx consist of a distal shaft connected to a push rod with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the push rod shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm). As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating.
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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17846 | Vascular guide-catheter, single-use | A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08718481740354 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223728 | 000 |