FDA UDI
In Commercial Distribution
🇺🇸 United States
ELEOS™
DI: B278PF2000L02M0
·
Model: PF-2000L-02M
·
ONKOS SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELEOS™
- Primary DI
- B278PF2000L02M0
- Version / Model
- PF-2000L-02M
- Catalog Number
- PF-2000L-02M
- Company Name
- ONKOS SURGICAL, INC.
- Labeler DUNS
- 080254074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-21
- Public Version
- 1
- Public Version Date
- 2020-07-29
- Public Version Status
- New
- Public Device Record Key
- 68b8c287-f98a-49fc-8361-7faaa2b70cdd
Device Description
ELEOS™ SEGMENTAL PROXIMAL FEMUR, PLASMA SPRAY, 98MM RESECTION, LEFT, 135 DEG
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | Orthopedic | 888.3350 | 2 |
| KRO | PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61559 | Femur/tibia shaft prosthesis | A sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve femoral/tibial extension, knee femur prosthesis, or body femoral/tibial extension stem; it is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B278PF2000L02M0 | HIBCC |
Customer Contacts
- Phone
- +1(844)767-2766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161520 | 000 |