FDA UDI
In Commercial Distribution
🇺🇸 United States
TK2™STANDARD BARREL
DI: 00887868051234
·
Model: 8315-30-005
·
Biomet Orthopedics, LLC
Product Codes
8
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TK2™STANDARD BARREL
- Primary DI
- 00887868051234
- Version / Model
- 8315-30-005
- Catalog Number
- 831530005
- 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
- 2024-02-19
- Public Version Status
- Update
- Public Device Record Key
- acca5482-8484-45c6-8ecc-6a4e86866ee0
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 |
|---|---|---|---|---|
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
| LXT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COMPOSITE | Orthopedic | 888.3030 | 2 |
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT | Orthopedic | 888.3030 | 2 |
| HWC | Screw, fixation, bone | Orthopedic | 888.3040 | 2 |
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
| HRS | PLATE, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
| HTN | WASHER, BOLT NUT | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34003 | Hip internal fixation system | An assembly of implantable devices designed to treat fractures of the hip. It typically includes a metal plate that is held in position with fasteners such as screws and nails, or bolts, nuts and washers. The assembly is typically intended to treat stable or unstable intertrochanteric, pertrochanteric, and/or base of neck hip fractures. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887868051234 | GS1 |
Customer Contacts
- Phone
- +1(800)348-9500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 130° 5 HOLE 110.6MM LENGTH |