FDA UDI
In Commercial Distribution
🇺🇸 United States
VERSANAIL®UNIVERSAL FEMORAL NAIL
DI: 00887868020162
·
Model: 1813-14-400
·
Biomet Orthopedics, LLC
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VERSANAIL®UNIVERSAL FEMORAL NAIL
- Primary DI
- 00887868020162
- Version / Model
- 1813-14-400
- Catalog Number
- 181314400
- Company Name
- Biomet Orthopedics, LLC
- Labeler DUNS
- 129278169
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-24
- Public Version
- 5
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 65f2dba7-de97-413f-8d48-68d6f25d7dfe
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
| HTN | WASHER, BOLT NUT | Orthopedic | 888.3030 | 2 |
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE | Orthopedic | 888.3030 | 2 |
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33187 | Femur nail | A rod made of metal or other material intended to be implanted into the intramedullary canal of the femur to immobilize the ends of a fractured bone in position to promote healing; it also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. It may be a locked or unlocked model and may include components to assist fixation of more proximal or distal conditions. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887868020162 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 14MM X 40CM |