FDA UDI
In Commercial Distribution
🇺🇸 United States
Ballista™ Percutaneous
DI: 00888480214311
·
Model: 2000-6904
·
BIOMET SPINE LLC
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ballista™ Percutaneous
- Primary DI
- 00888480214311
- Version / Model
- 2000-6904
- Catalog Number
- 2000-6904
- Company Name
- BIOMET SPINE LLC
- Labeler DUNS
- 018577570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-28
- Public Version
- 4
- Public Version Date
- 2022-11-28
- Public Version Status
- Update
- Public Device Record Key
- c7f69f67-b8a7-4da0-8b1f-e71b88e02e28
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL | Orthopedic | 888.3050 | 2 |
| MNI | Orthosis, spinal pedicle fixation | Orthopedic | 888.3070 | 2 |
| KWQ | Appliance, fixation, spinal intervertebral body | Orthopedic | 888.3060 | 2 |
| NKB | Thoracolumbosacral pedicle screw system | Orthopedic | 888.3070 | 2 |
| MNH | Orthosis, spondylolisthesis spinal fixation | Orthopedic | 888.3070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61235 | Cannulated surgical drill bit, single-use | A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888480214311 | GS1 |
Customer Contacts
- Phone
- +1(800)447-3625
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | BLUNT GUIDEWIRE 1.6MM X 510MM PEDICLE SCREW SYSTEM |