FDA UDI
In Commercial Distribution
🇺🇸 United States
Smart Correction
DI: B56250106200SWBSP0
·
Model: 50-1062-00S-WBSP
·
Wishbone Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Smart Correction
- Primary DI
- B56250106200SWBSP0
- Version / Model
- 50-1062-00S-WBSP
- Catalog Number
- 50-1062-00S-WBSP
- 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
- 3
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- 843669c9-7c84-4f22-981b-b267487e7c93
Device Description
Wire Stopper Washer, SS (3-Pack) - Sterile
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61467 | General external orthopaedic fixation system implantation kit, single-use | A collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B56250106200SWBSP0 | HIBCC |
Customer Contacts
- Phone
- (574) 306-4006
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K193368 | 000 |