FDA UDI
In Commercial Distribution
🇺🇸 United States
Balloon Catheter Curved
DI: 06938695537836
·
Model: LC10215
·
Shanghai Kinetic Medical Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Balloon Catheter Curved
- Primary DI
- 06938695537836
- Version / Model
- LC10215
- Catalog Number
- LC10215
- Company Name
- Shanghai Kinetic Medical Co., Ltd.
- Labeler DUNS
- 528198569
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-31
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 67b72f39-7a92-4d36-8004-e7c5b8fcaead
Device Description
Balloon Catheter Curved, 15mm, 45°
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
- Yes
- 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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58031 | Bone access channel kit | A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06938695537836 | GS1 |
Customer Contacts
- Phone
- +862150720558
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113742 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Balloon Length | 15 | Millimeter | |
| Angle | 45 | degree |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius