FDA UDI
In Commercial Distribution
🇺🇸 United States
GUARDIAN Inflatable Bone Expander System
DI: 08809255542219
·
Model: BMK-CM
·
BM KOREA CO., LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- GUARDIAN Inflatable Bone Expander System
- Primary DI
- 08809255542219
- Version / Model
- BMK-CM
- Company Name
- BM KOREA CO., LTD
- Labeler DUNS
- 557799209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-14
- Public Version
- 5
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 489f02eb-bc0e-44c3-b203-bbeffa1a94d0
Device Description
The GUARDIAN Inflatable Bone Expander System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN Inflatable Bone Expander System are the significant reduction in back pain and increase patient’s functional abilities, allow a return it the previous level of activity.
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 |
|---|---|---|---|---|
| 17541 | Catheter/overtube balloon inflator, single-use | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08809255544213 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08809255542219 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111593 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 229.58 | Millimeter |