FDA UDI
In Commercial Distribution
🇺🇸 United States
SurVeil DCB
DI: 00812339030418
·
Model: SRV03513505080
·
Surmodics, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SurVeil DCB
- Primary DI
- 00812339030418
- Version / Model
- SRV03513505080
- Company Name
- Surmodics, Inc.
- Labeler DUNS
- 098414659
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-04
- Public Version
- 1
- Public Version Date
- 2023-10-12
- Public Version Status
- New
- Public Device Record Key
- 294f620c-e7a9-4077-9443-e2dfa28a71f0
Device Description
SurVeil DCB 5.0mm x 80mm x 135cm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ONU | Drug-Eluting Peripheral Transluminal Angioplasty Catheter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62551 | Peripheral angioplasty balloon catheter, drug-coated | A sterile, flexible tube designed for percutaneous transluminal angioplasty (PTA) to dilate a stenotic peripheral (i.e., non-cerebral, non-coronary) artery by controlled inflation of a distensible balloon(s) at its distal tip, and to simultaneously release a drug intended to inhibit restenosis; it may also be intended for positioning and expansion of a stent/stent-graft. It is available as an over-the-wire (OTW) type with multiple lumens, or a rapid exchange (RX) type with a single-lumen. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812339030418 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P210025 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Diameter | 5 | Millimeter | |
| Balloon Length | 80 | Millimeter | |
| Catheter Length | 135 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius