FDA UDI
In Commercial Distribution
🇺🇸 United States
ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY
DI: B278AMMS070MF0
·
Model: AM-MS-070MF
·
ONKOS SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY
- Primary DI
- B278AMMS070MF0
- Version / Model
- AM-MS-070MF
- Company Name
- ONKOS SURGICAL, INC.
- Labeler DUNS
- 080254074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-13
- Public Version
- 2
- Public Version Date
- 2024-12-24
- Public Version Status
- Update
- Public Device Record Key
- 8f76b7f0-2f25-4e57-a634-4d07a85257e9
Device Description
ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY ANTIBACTERIAL COATED MALE-FEMALE MIDSECTION SIZE 70MM
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QZZ | Limb And Joint Salvage Device With Coating For Bacteria Reduction | Orthopedic | 888.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61562 | Body femoral/tibial extension stem, coated | A sterile implantable device intended to provide an extension of, or coupling with, other components of a modular femoral/tibial prosthesis in the medullary canal to compensate for bone loss during revision arthroplasty or bone resection. The device is a solid/dense body made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B278AMMS070MF0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210058 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 70 | Millimeter |