FDA UDI
In Commercial Distribution
🇺🇸 United States
B-P TOTAL HIP SYSTEM
DI: 00814193022752
·
Model: 01-02-2856
·
Synovo Production
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- B-P TOTAL HIP SYSTEM
- Primary DI
- 00814193022752
- Version / Model
- 01-02-2856
- Catalog Number
- 01-02-2856
- Company Name
- Synovo Production
- Labeler DUNS
- 061486164
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2024-02-22
- Public Version Status
- Update
- Public Device Record Key
- 60ba50c6-28d0-493b-92e3-d587d85b1b11
Device Description
B-P HIP ACETABULAR BEARING - 28 MM I.D. X 56 MM O.D.
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 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Orthopedic | 888.3358 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33715 | Ceramic-on-polyethylene total hip prosthesis | A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a ceramic-on-polyethylene or cross-linked polyethylene (PE) interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814193022752 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K963101 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 56 | Millimeter | |
| Lumen/Inner Diameter | 28 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius