FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Consensus® Hip System
DI: 00844588000362
·
Model: 0009-0-0020
·
CONSENSUS ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Consensus® Hip System
- Primary DI
- 00844588000362
- Version / Model
- 0009-0-0020
- Catalog Number
- 0009-0-0020
- Company Name
- CONSENSUS ORTHOPEDICS, INC.
- Labeler DUNS
- 824905723
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 3
- Public Version Date
- 2021-07-29
- Public Version Status
- Update
- Public Device Record Key
- fec43594-6c7f-4d39-8fbd-264b5a54a63e
- Distribution End Date
- 2021-07-28
Device Description
Distal Centralizer
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| JDL | Prosthesis, hip, semi-constrained (metal cemented acetabular component) | Orthopedic | 888.3320 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33989 | Uncoated femoral stem prosthesis, one-piece | A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is one-piece, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844588000362 | GS1 |
Customer Contacts
- Phone
- +1(916)355-7100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 20 | Millimeter |