FDA UDI
In Commercial Distribution
🇺🇸 United States
ELOS INSTRUMENTS
DI: 08056693000577
·
Model: SE235
·
INTRAUMA SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ELOS INSTRUMENTS
- Primary DI
- 08056693000577
- Version / Model
- SE235
- Catalog Number
- SE235
- Company Name
- INTRAUMA SPA
- Labeler DUNS
- 387588051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-20
- Public Version
- 4
- Public Version Date
- 2025-11-28
- Public Version Status
- Update
- Public Device Record Key
- 43593311-171a-4378-8388-9066b38893d7
Device Description
Compression Rod
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47875 | Bone-nailing compression screw | A rod-like orthopaedic surgical instrument designed to be inserted (screwed) through the insertion handle of an orthopaedic implant aiming arm to impart a force upon a proximally inserted bone nail locking screw thus creating compression on the proximal section of a fractured bone to close the fracture gap with the distal section which can then be locked into final position. It is typically made of high-grade stainless steel and has a threaded portion at the proximal end together with a head for acceptance of a screwdriver or other tool to provide the necessary rotation. It is available in a variety of lengths and is usually used when nailing the tibia or humerus. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08056693000577 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201147 | 000 |