FDA UDI
In Commercial Distribution
🇺🇸 United States
Bespa Charcot System
DI: 00810041320247
·
Model: BSP01-6-1501-06
·
Kapstone Manufacturing, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Bespa Charcot System
- Primary DI
- 00810041320247
- Version / Model
- BSP01-6-1501-06
- Catalog Number
- BSP01-6-1501-06
- Company Name
- Kapstone Manufacturing, LLC
- Labeler DUNS
- 074092521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-16
- Public Version
- 2
- Public Version Date
- 2024-12-13
- Public Version Status
- Update
- Public Device Record Key
- 04b0f22d-0c12-40e1-a427-d7830a617d53
Device Description
Segmental Column Alignment Plate
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62709 | Intermedullary nail screw-alignment receiver | A sterile device intended to use magnetic field alignment for inserting correctly aligned screws into the distal screw holes of an intermedullary nail (e.g., femur nail, tibia nail). It consists of a magnet within a holding case that is attached to an external implant aiming arm, which can align with a magnet inserted into the distal end of the nail. It is typically then replaced with a screw guide for screw insertion. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810041320247 | GS1 |