FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10886982231352
·
Model: 459.28
·
SYNTHES (U.S.A.) LP
Product Codes
5
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886982231352
- Version / Model
- 459.28
- Catalog Number
- 45928
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-14
- Public Version
- 5
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 5dc1226f-d1cb-4666-8ab6-b068027ee496
- Distribution End Date
- 2020-07-23
Device Description
4.9MM TI LOCKING BOLT 28MM
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 |
|---|---|---|---|---|
| JDN | IMPLANT, FIXATION DEVICE, SPINAL | Orthopedic | 888.3060 | 2 |
| HTY | PIN, FIXATION, SMOOTH | Orthopedic | 888.3040 | 2 |
| JDS | NAIL, FIXATION, BONE | Orthopedic | 888.3030 | 2 |
| JDW | PIN, FIXATION, THREADED | Orthopedic | 888.3040 | 2 |
| HSB | ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16077 | Orthopaedic bone bolt | A short rod or shaft designed to be inserted through a long bone in order to secure the bone for traction or for a similar process/apparatus. The device is fastened with a nut/washer, and is typically made of metal or a polymer. It is typically used in the proximal tibia or distal femur. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H679459280 | HIBCC | ||||
| Primary | 10886982231352 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]