FDA UDI
In Commercial Distribution
🇺🇸 United States
GUARDIAN-SG Inflatable Bone Expander System
DI: 08809255542639
·
Model: BMK(T)15αS
·
BM KOREA CO., LTD
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GUARDIAN-SG Inflatable Bone Expander System
- Primary DI
- 08809255542639
- Version / Model
- BMK(T)15αS
- Company Name
- BM KOREA CO., LTD
- Labeler DUNS
- 557799209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-21
- Public Version
- 5
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 91e119ef-2f23-4c20-b3d4-7f7af07a8d6f
Device Description
The GUARDIAN-SG Inflatable Bone Expander System is intended to be used for the reduction of fracture and/or creation of a void in cancellous bone in the spine.
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
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | Orthopedic | 888.3027 | 2 |
| HRX | Arthroscope | Orthopedic | 888.1100 | 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 | 08809255544633 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08809255542639 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143006 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- temperature limitation, from -10℃ to 25℃