ELEOS™
- Primary DI
- B27800203000090
- Brand
- ELEOS™
- Company
- ONKOS SURGICAL, INC.
- Model
- 002-03-00009
- Catalog number
- 002-03-00009
- Device description
- ELEOS™ INSTRUMENTATION TRAY, 9
- Published
- 2020-03-19
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| FSM | TRAY, SURGICAL, INSTRUMENT |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FSM | Tray, Surgical, Instrument | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B27800203000090 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Instrument tray | A container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 080254074
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- true
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| B278DV3500004N0 | My3D® Personalized Pelvic Reconstruction | DV-35000-04N | | 2025-09-22 |
| B278DVMOD3504N0 | My3D® Personalized Pelvic Reconstruction | DV-MOD35-04N | | 2025-09-22 |
| B278DVRDG3504N0 | My3D® Personalized Pelvic Reconstruction | DV-RGD35-04N | | 2025-09-22 |
| B278AMMS040MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-040MF | | 2024-12-13 |
| B278AMMS050MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-050MF | | 2024-12-13 |
| B278AMMS060MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-060MF | | 2024-12-13 |
| B278AMMS070MF0 | ELEOS LIMB SALVAGE SYSTEM WITH NANOCEPT TECHNOLOGY | AM-MS-070MF | | 2024-12-13 |
| B278IMBCEXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imbc/ExSm | IMBC-EXSM | 2024-07-23 |
| B278JTSDFLSTD0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-L-STD | JTSDF-L-STD | 2024-07-23 |
| B278TMKTPEXSM50 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | tmktp/ExSm5 | TMKTP-EXSM5 | 2024-07-23 |
| B278IMARDRL0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imardrl | IMARDRL | 2024-07-22 |
| B278IMAXCP0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imaxcp | IMAXCP | 2024-07-22 |
| B278IMBCSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | imbc/Sm | IMBC-SM | 2024-07-22 |
| B278IMPBIMPEXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | impbimp/ExSm | IMPBIMP-EXSM | 2024-07-22 |
| B278IMPBIMPSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | impbimp/Sm | IMPBIMP-SM | 2024-07-22 |
| B278JTSDFLSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-L-SM | JTSDF-L-SM | 2024-07-22 |
| B278JTSDFRSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-R-SM | JTSDF-R-SM | 2024-07-22 |
| B278JTSDFRXSM0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | JTSDF-R-XSM | JTSDF-R-XSM | 2024-07-22 |
| B278JTSDRIVEUNIT0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | MLE3 | JTS-DRIVE-UNIT | 2024-07-22 |
| B278PIN0 | JTS EXTENDIBLE DISTAL FEMORAL IMPLANT | ictjigsh | PIN | 2024-07-22 |
Other Devices Sharing Product Codes