FDA UDI
In Commercial Distribution
🇺🇸 United States
OSCAR 3
DI: 18056099649728
·
Model: 1
·
ORTHOFIX SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSCAR 3
- Primary DI
- 18056099649728
- Version / Model
- 1
- Catalog Number
- OHP2131
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-18
- Public Version
- 4
- Public Version Date
- 2018-07-24
- Public Version Status
- Update
- Public Device Record Key
- 4af292e6-cbca-46c0-b89a-09ba16be1f36
Device Description
13MM PIERCER PROBE - 180MM
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
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LZV | System, Cement Removal Extraction | Orthopedic | 888.4580 | 2 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | Orthopedic | 888.4580 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45981 | Hard-tissue ultrasonic surgical system | An assembly of devices designed to use ultrasonic energy to mechanically fragment and cut bone and/or bone cement [e.g., acrylic, polymethylmethacrylate (PMMA)] upon contact during an orthopaedic surgical procedure (e.g., arthroplasty revision, spinal surgery); some types may in addition be intended for dental/craniomaxillofacial applications (e.g., reconstructive/plastic surgery) however none are dedicated exclusively to dental applications. It typically includes an ultrasonic energy-producing generator, a handpiece with cutting tip(s)/probe(s) to apply the energy and remove (aspirate) material, and connecting cables. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18056099649728 | GS1 |
Customer Contacts
- Phone
- +0390456719000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093805 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 180 | Millimeter |