FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter
DI: 08058964726339
·
Model: 900027
·
G21 SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter
- Primary DI
- 08058964726339
- Version / Model
- 900027
- Catalog Number
- 900027
- Company Name
- G21 SRL
- Labeler DUNS
- 431529195
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-17
- Public Version
- 3
- Public Version Date
- 2023-03-06
- Public Version Status
- Update
- Public Device Record Key
- 1c756eb3-1406-4b06-ab50-b31b3f068ff1
- Distribution End Date
- 2017-10-09
Device Description
Kyphoplasty Balloon Catheter
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 |
|---|---|---|---|---|
| HRX | Arthroscope | Orthopedic | 888.1100 | 2 |
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47021 | Inflatable bone tamp | A catheter-like device with an inflatable balloon at the distal end used for the reduction of fractures and/or creation of a void in cancellous bone [e.g., in the spine for a vertebral compression fracture (VCF), hand, tibia, radius, and calcaneus]. It is commonly used for kyphoplasty, which involves its insertion into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated. After the device is removed, orthopaedic bone cement is introduced into the created void to stabilize the vertebra. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08058964726339 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152557 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit