FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Instrument
DI: 05060296233754
·
Model: imostme/15
·
Stanmore Implants Worldwide Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Instrument
- Primary DI
- 05060296233754
- Version / Model
- imostme/15
- Catalog Number
- IMOSTME-15
- Company Name
- Stanmore Implants Worldwide Ltd
- Labeler DUNS
- 494989502
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-18
- Public Version
- 2
- Public Version Date
- 2023-06-05
- Public Version Status
- Update
- Public Device Record Key
- d46b23d2-5b9b-45ff-b058-5b897ed25f87
- Distribution End Date
- 2023-06-02
Device Description
Osteotome
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
- No
- 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 |
|---|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12844 | Orthopaedic osteotome | A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060296233754 | GS1 |