FDA UDI
In Commercial Distribution
🇺🇸 United States
Dymaxeon
DI: 00815500023530
·
Model: 05.5
·
BACK 2 BASIC DIRECT, LLC
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dymaxeon
- Primary DI
- 00815500023530
- Version / Model
- 05.5
- Catalog Number
- 09.0643
- Company Name
- BACK 2 BASIC DIRECT, LLC
- Labeler DUNS
- 043841348
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-21
- Public Version
- 3
- Public Version Date
- 2018-08-09
- Public Version Status
- Update
- Public Device Record Key
- 29d46313-a251-44ae-b693-871924498e8d
Device Description
DYMAXEON T-HANDLE - QUICK CONNECT
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
- MR Conditional
- 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
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | Orthopedic | 888.3070 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Orthopedic | 888.3070 | 2 |
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 | 00815500023530 | GS1 |
Customer Contacts
- Phone
- 2164475025
- [email protected]