FDA UDI
In Commercial Distribution
🇺🇸 United States
OSCAR
DI: 05060201560647
·
Model: 1
·
ORTHOSONICS LIMITED
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OSCAR
- Primary DI
- 05060201560647
- Version / Model
- 1
- Catalog Number
- OHB300
- Company Name
- ORTHOSONICS LIMITED
- Labeler DUNS
- 505987040
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-10
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 54085915-f50b-40ce-8ad0-6415285cf91c
Device Description
Oscar II Handset - Bonecutter
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
- Yes
- 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 |
|---|---|---|---|---|
| 44598 | Orthopaedic cement extractor, electric | A hand-operated, electrically-powered surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other power operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060201560647 | GS1 |
Customer Contacts
- Phone
- +4401628594500
- [email protected]