FDA UDI
In Commercial Distribution
🇺🇸 United States
LSSS
DI: 05060433600876
·
Model: RM06006
·
Lockdown Medical Ltd
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LSSS
- Primary DI
- 05060433600876
- Version / Model
- RM06006
- Catalog Number
- RM06006
- Company Name
- Lockdown Medical Ltd
- Labeler DUNS
- 211167885
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-24
- Public Version
- 1
- Public Version Date
- 2020-08-03
- Public Version Status
- New
- Public Device Record Key
- 6ddb2faf-1643-4d1d-b120-fb202a4f4fe6
Device Description
AO CANNULATED SILICONE SCREWDRIVER HANDLE WITH QUICK COUPLING. THE "AO SCREWDRIVER SPINNER" - DI NO# (05060433600883) SCREWS ONTO THE END OF THIS DEVICE. THIS CREATES THE FINAL INSTRUMENT IN630/1 - "AO CANNULATED HANDLE WITH QUICK COUPLING AND SPINNER - AS01068"
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["High-level Disinfectant", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LRZ | Screwdriver, Surgical | General, Plastic Surgery | 878.4800 | 1 |
| HXX | Screwdriver | Orthopedic | 888.4540 | 1 |
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47829 | Surgical instrument handle, non-torque-limiting | A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060433600876 | GS1 |