FDA UDI
In Commercial Distribution
🇺🇸 United States
MultiCross Catheter
DI: B094MC01000
·
Model: MC-0100
·
ROXWOOD MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MultiCross Catheter
- Primary DI
- B094MC01000
- Version / Model
- MC-0100
- Company Name
- ROXWOOD MEDICAL, INC.
- Labeler DUNS
- 055819211
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-27
- Public Version
- 3
- Public Version Date
- 2024-08-07
- Public Version Status
- Update
- Public Device Record Key
- 3eae8ed6-7b23-4c2e-ba2a-ef2fa7fb89b5
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 |
|---|---|---|---|---|
| 46719 | Atheroma crossing microdissection catheter, coronary | A manually-powered (non-electronic) instrument intended to be used to create a pathway through an occluded coronary artery to facilitate the intraluminal placement of a conventional guidewire beyond a stenotic lesion [chronic total occlusion (CTO)], prior to further percutaneous intervention to remove the lesion. It typically consists of a long, thin, flexible segment, introduced into the vasculature, that is equipped to mechanically disrupt the lesion (e.g., by blunt microdissection) through manipulation of hand controls at the proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B094MC01000 | HIBCC |