FDA UDI
In Commercial Distribution
🇺🇸 United States
SWANSON
DI: 00840420127471
·
Model: G4260102
·
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SWANSON
- Primary DI
- 00840420127471
- Version / Model
- G4260102
- Catalog Number
- G4260102
- Company Name
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 807201207
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-15
- Public Version
- 5
- Public Version Date
- 2022-05-17
- Public Version Status
- Update
- Public Device Record Key
- 6487ab24-3a34-4e73-8e58-45053b037149
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 |
|---|---|---|---|---|
| KWH | PROSTHESIS, TOE, CONSTRAINED, POLYMER | Orthopedic | 888.3720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61601 | Total metatarsophalangeal joint prosthesis, modular | An implantable substitute for the metatarsophalangeal (MTP) joint of the foot (toe) intended to repair both articulating surfaces with matching metatarsal and phalangeal components, typically to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] and polymer materials and implantation may be performed with or without bone cement. Disposable instruments associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840420127471 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7117
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size: #2S |