FDA UDI
In Commercial Distribution
🇺🇸 United States
LCS COMPLETE
DI: 10603295022664
·
Model: 1294-09-660
·
DEPUY (IRELAND)
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LCS COMPLETE
- Primary DI
- 10603295022664
- Version / Model
- 1294-09-660
- Catalog Number
- 129409660
- Company Name
- DEPUY (IRELAND)
- Labeler DUNS
- 989365556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-03-24
- Public Version
- 5
- Public Version Date
- 2021-05-14
- Public Version Status
- Update
- Public Device Record Key
- 2f5f9431-b53b-4c50-b43b-2b1b4be4596c
Device Description
LCS COMPLETE Metal Backed Patella CEMENTLESS POROCOAT LRG
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
- 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 |
|---|---|---|---|---|
| NJL | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34192 | Metal-backed patella prosthesis | An implantable device covered with metal on its outer surface intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10603295022664 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]