FDA UDI
In Commercial Distribution
🇺🇸 United States
WishBone K - Wire System
DI: B562KWSB0
·
Model: KWSB
·
Wishbone Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WishBone K - Wire System
- Primary DI
- B562KWSB0
- Version / Model
- KWSB
- Catalog Number
- KWSB
- Company Name
- Wishbone Medical, Inc.
- Labeler DUNS
- 062355158
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-30
- Public Version
- 6
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 9dcebccd-d70f-4bbe-adb6-95e8eae0c3e4
Device Description
K-wire sports balls tip proctector, 3 pack
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65406 | Orthopaedic bone pin cover | A small device intended to enclose/cover the protruding end of an orthopaedic bone pin [e.g., Kirschner wire (K-Wire)] to prevent snagging objects in the environment and injury or discomfort to the patient while the wire is in situ. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B562KWSB0 | HIBCC |