FDA UDI
In Commercial Distribution
🇺🇸 United States
SWANSON
DI: 00840420121509
·
Model: 4260007
·
WRIGHT MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SWANSON
- Primary DI
- 00840420121509
- Version / Model
- 4260007
- Catalog Number
- 4260007
- 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
- 47e203e3-4770-4981-aa0a-a89e1be1caee
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 |
|---|---|---|---|---|
| 33700 | Total metatarsophalangeal joint prosthesis, one-piece | An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840420121509 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7117
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size: 7 |