FDA UDI
In Commercial Distribution
🇺🇸 United States
Diamond Orthopedic, LLC
DI: B551DMD319292
·
Model: DMD-319-292
·
DIAMOND ORTHOPEDIC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Diamond Orthopedic, LLC
- Primary DI
- B551DMD319292
- Version / Model
- DMD-319-292
- Catalog Number
- DMD-319-292
- Company Name
- DIAMOND ORTHOPEDIC, LLC
- Labeler DUNS
- 080596041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- d3a6e6da-a344-46a7-9685-3d8492cd0b1e
Device Description
Cleaning Stylet - 1.1mm, Length 150mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44802 | Orthopaedic instrument cleaning tool | A hand-held manual device designed to clean the residual tissue or debris that remains embedded on or in an orthopaedic surgical instrument (e.g., reamers, bone taps) following use. The device can be in the form of wire or a strip of metal. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B551DMD319292 | HIBCC |
Customer Contacts
- Phone
- 704-585-8270
- [email protected]