FDA UDI
In Commercial Distribution
🇺🇸 United States
SILKTOE INSTRUMENT
DI: 08053782780327
·
Model: Silktoe Cutting Guide holder
·
BRM EXTREMITIES SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SILKTOE INSTRUMENT
- Primary DI
- 08053782780327
- Version / Model
- Silktoe Cutting Guide holder
- Catalog Number
- BRDNPTCGMASK
- Company Name
- BRM EXTREMITIES SRL
- Labeler DUNS
- 435126746
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-10
- Public Version
- 1
- Public Version Date
- 2025-07-18
- Public Version Status
- New
- Public Device Record Key
- e8c06606-e5af-4143-9883-75860d2920f5
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
- Yes
- 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 |
|---|---|---|---|---|
| 59009 | Orthopaedic implant/instrument assembling device | A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08053782780327 | GS1 |
Customer Contacts
- Phone
- +39 03411693087
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 40-50 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature, keep dry and away from humidity and direct sources of light and heat.