FDA UDI
In Commercial Distribution
🇺🇸 United States
OSCAR
DI: 05060201560586
·
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
- 05060201560586
- Version / Model
- 1
- Catalog Number
- OHSO2060SU
- 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
- 8939175f-cdcd-4c63-8bfd-300ec3b7c23f
Device Description
Single Use 6mm Serrated Osteotome – Sterile
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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|
| 37065 | Ultrasonic orthopaedic cement extractor | A hand-operated, electrically-powered surgical instrument that uses ultrasonic energy for the extraction of orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include an aspirating device for the removal of cement/bone fragments. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060201560586 | GS1 |
Customer Contacts
- Phone
- +4401628594500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 6 | Millimeter |