FDA UDI
In Commercial Distribution
🇺🇸 United States
JOURNEY
DI: 03596010573308
·
Model: 71461010
·
Smith & Nephew, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- JOURNEY
- Primary DI
- 03596010573308
- Version / Model
- 71461010
- Catalog Number
- 71461010
- Company Name
- Smith & Nephew, Inc.
- Labeler DUNS
- 045483575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-08-30
- Public Version
- 6
- Public Version Date
- 2025-11-27
- Public Version Status
- Update
- Public Device Record Key
- 5fb49fba-383f-452c-b1d3-6e6852a7ae2d
Device Description
JOURNEY PFJ IMPLANT EXTRA-SMALL LEFT
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
- MR Conditional
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KRR | PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3540 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58227 | Patellofemoral joint prosthesis | A sterile implantable device designed to replace the patellofemoral articulating surface of the knee to treat isolated patellofemoral disease, typically osteoarthritis. The device is made of metal (e.g., oxidized zirconium alloy) and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth; it may include fixation devices (e.g., pegs) for implantation which is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03596010573308 | GS1 |
Customer Contacts
- Phone
- +1(800)238-7538
- [email protected]