FDA UDI
In Commercial Distribution
🇺🇸 United States
SWANSON
DI: 00840420129185
·
Model: 482303R
·
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SWANSON
- Primary DI
- 00840420129185
- Version / Model
- 482303R
- Catalog Number
- 482303R
- Company Name
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 807201207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-01
- Public Version
- 4
- Public Version Date
- 2022-05-17
- Public Version Status
- Update
- Public Device Record Key
- 5856744e-c2e2-4e46-b614-d6003eb67f85
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 |
|---|---|---|---|---|
| KWO | PROSTHESIS, WRIST, CARPAL SCAPHOID | Orthopedic | 888.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33707 | Carpal scaphoid prosthesis | A sterile implantable device designed to replace the scaphoid bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840420129185 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7117
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size: 3 | ||
| Device Size Text, specify | Right |