FDA UDI
In Commercial Distribution
🇺🇸 United States
BENCOX Hip System
DI: 08806373850141
·
Model: H1.C11.0005
·
Corentec Co., Ltd
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BENCOX Hip System
- Primary DI
- 08806373850141
- Version / Model
- H1.C11.0005
- Company Name
- Corentec Co., Ltd
- Labeler DUNS
- 688739895
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-05-04
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f0cfcf06-0019-4f71-8d23-ffdd815133f4
Device Description
Deformabla Centralizer 17.5mm (for No .5)
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 |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Orthopedic | 888.3390 | 2 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Orthopedic | 888.3353 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61271 | Femoral stem centralizer | A small sterile implantable device intended to be used during the implantation of a cemented femoral stem prosthesis to centralize and stabilize the prosthesis tip within the femoral medullary canal; it is inserted into the medullary canal prior to cement insertion. It is made of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] and may have a winged structure. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08806373850141 | GS1 |
Customer Contacts
- Phone
- +820415857114
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152084 | 000 |